Jobs That Crossed My Desk Through Sept - Audrey' s Network
Jobs That Crossed My Desk Through Feb. 14, 2010
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
Dave Murphy
Managing Partner
The Alpine Group
970-241-4043 ext 112 (Office)
970-241-4395 (Fax)
dave@
Medical Device Marketing – Capital Equipment--San Francisco
Like to build things?
A small, high-growth medical device company is expanding its commercial team and has created a new Product Manager / Sr. Product Manager position in their marketing group. This 12 year old, multi-national organization manufacturers laser equipment for use in surgical procedures. Well capitalized and profitable, they enjoy a large base of currently installed equipment and are looking to expand in new therapeutic areas. Although it is a small marketing group, this is a dynamic, exciting work environment and their teams have unusually strong personal chemistry. If you’re looking for a strategic challenge in an organization that is building a foundation for the future, then this could be the opportunity for you.
The opportunity
Reporting to the VP of Marketing, the Product Manager will create and implement the marketing strategy for a line of highly innovative laser equipment with multiple clinical applications, including dermatology and aesthetics. This is a broadly defined, global role where you will develop and execute promotional plans for your assigned products. Specific duties include product positioning, messaging, budgeting, forecasting, and monitoring competitive activity. You will also work closely with direct sales reps and distributors in different regions to implement new sales tools and local educational programs. Estimated travel for the position is 50%.
In this high profile assignment you will present product launch plans and recommendations to senior management on a routine basis. You will also be expected to develop strong relationships with Key Opinion Leaders and develop them as advocates for your technology. You will work cross-functionally with a broad range of different departments, including R&D, Regulatory, and Finance. The small size of this new team means that you will “wear many hats” in this role. A rapidly expanding organization means significant opportunity exists for senior management and career development - we are looking to hire someone who can advance at least two levels within the organization during the course of their career.
Qualifications:
We are looking for someone with the following qualities needed for success in this role:
• 5+ years of marketing experience in the Medical Device industry, with a preference for surgical equipment marketing experience.
• Evidence of successful product launch experience of a medical technology
• Experience working with a highly trained, technically oriented sales organization
• Bachelor’s degree or better; MBA preferred
• Strong analytical and presentations skills
A highly competitive base salary (110-135K), cash bonus (10%) and stock option plan is provided, along with a comprehensive benefits package. This is an opportunity to leverage your experience and relationships for something more than a simple paycheck.
If you are a self-starter who enjoys the challenges and rewards of working with cutting-edge technology, and if your background meets these qualifications, please apply. We want to give you the opportunity to succeed.
PERSONAL PRIVACY AND CONFIDENTIALITY IS GUARANTEED. No telephone calls please. Qualified candidates will be contacted as appropriate.
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Contact:
please reply to jobs@
Veracyte Laboratory Technologist (CLS) South San Francisco
Reports To: Dr. William Seltzer, SVP, Laboratory Operations
The Laboratory Technologist (CLS) in this CLIA Laboratory is responsible for the processing of clinical specimens, performing testing and recording of test results.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Laboratory Technologist will be accountable for the following activities:
• Perform molecular genetic testing on clinical specimens
• Follow the laboratory's standard operating procedures for specimen handling and processing, test analyses, recording of test results
• Adhere to the laboratory's quality control policies and document all quality control activities, instrument and procedural calibrations and maintenance performed
• Perform all laboratory activities in accordance with the Quality Assurance Program
• Engage in training and competency assessment
• Perform proficiency testing for the clinical tests
• Follow the laboratory's established policies
• Identify problems that may adversely affect test performance or reporting of test results
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
• Attend and participate in the monthly quality assurance meetings
• Participate in activities associated with regulatory compliance and inspections
• Contribute to the safety of the laboratory operations
• Be accountable for customer satisfaction and the quality of the testing services
• Work cooperatively in a team environment supporting senior laboratory and management staff
Education, Training, and Work Experience Requirements
• The Laboratory Technologist holds a B.A, B.S., M.A. or M.S. in chemical, physical, biological science or medical technology from an accredited institution
• The Laboratory Technologist should have a minimum of two years clinical laboratory experience in molecular genetic testing
• The Laboratory Technologist holds a current California State Clinical Laboratory Scientist (CLS) license as a Clinical Genetics Molecular Biologist
Other Skills and Attributes
• Excellent problem solving skills; demonstrated strength in tact and diplomacy with internal and external collaborators
• Ability to work independently and exercise good judgment
• Excellent teamwork and collaboration skills
• Excellent written and oral communication skills
• Excellent interpersonal skills
****************************************************************************
Contact:
please reply to jobs@
Veracyte - General Supervisor, High Complexity CLIA Laboratory-South San Francisco
Reports To: Dr. William Seltzer, SVP, Laboratory Operations
The General Supervisor of this High Complexity CLIA Laboratory is a hands-on position responsible for the day-to-day supervision and oversight of the clinical laboratory’s operations and personnel performing testing and reporting of test results.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The General Supervisor will be accountable for the following activities:
• Ordering and managing inventory and installation and qualification of laboratory supplies, reagents and equipment.
• Ensuring operational compliance with the clinical laboratory’s Quality Management Systems (QMS) Program and delivering the routine QMS associated metrics
• Training and proficiency in the laboratory’s Standard Operating Procedures (SOPs) for clinical testing and knowledgeable in their quality control parameters.
• Providing hands on back-up support to the testing personnel in the performance of all operational clinical tests as required to meet service imperative.
• Training, supervising, and assessing the competency of testing personnel.
• Providing day-to-day supervision of high complexity test performance by qualified testing personnel
• Monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained
• Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning
• Providing orientation to all testing personnel
• Annually evaluating and documenting the performance of all testing personnel
• Coordinating laboratory activities to complement the duties and responsibilities of the Quality Assurance Manager.
• Participate in the monthly QMS meetings, presenting activities and metric outcomes to review and assess compliance, developing and implementing remedial activity plans, as needed, and activities for quality improvement
• Coordinating activities and preparing for regulatory inspections
• Accountable for customer satisfaction
? Work cooperatively in a team environment: supporting senior laboratory and management staff.
Education, Training and Work Experience Requirements
The Supervisor holds a B.A, B.S., M.A. or M.S. in chemical, physical, or biological science from an accredited institution
• The supervisor is qualified as a medical technologist and has had at least six years of pertinent clinical laboratory experience subsequent to qualifying of which at least two years have been spent working in a clinical laboratory qualified to perform high complexity genetic testing and having a director at the doctoral level.
• The Supervisor holds a current California State Clinical Laboratory Scientist (CLS) license as a Clinical Genetics Molecular Biologist.
• Practical and hand-on experience in Quality Management Systems (QMS)
Other Skills and Attributes
Excellent problem solving skills; demonstrated strength in tact and diplomacy with internal and external collaborators
• Ability to work independently; exercise good judgment
• Excellent teamwork and collaboration skills
• Excellent written and oral communication skills
• Excellent interpersonal skills
***********************************************************************
CONTACT:
If interested, send your resume to george@.
Supervisor, Medical Writing – St. Louis, MO
In-house opportunity
SUMMARY OF POSITION:
This individual has full responsibility for facilitating and managing assigned medical writing personnel and the preparation of clinical documents such as protocol synopses and protocols, clinical study reports (CSR), integrated summary documents, clinical portions of INDAs NDAs, ANDAs, as well as SOPs. The principal will develop processes and templates for clinical documents. The principal will also be responsible for the line management of a Senior Medical Writer and an Associate Medical Writer.
ESSENTIAL FUNCTIONS:
1. Will plan, write, edit, and review 100% of clinical documents including, but not exclusive to, protocol synopses, clinical protocols, clinical study reports (CSRs), integrated summary documents, clinical portions of INDAs, NDAs, ANDAs, and the creation of SOPs.
2. Will be responsible for developing processes and templates for all clinical documents.
3. Will be responsible for the line management of a Senior Medical Writer and Associate Medical Writer. These duties will include hiring, performance planning, and evaluation.
4. The principal will review all documents created and edited by the Senior Medical Writer and Associate Medical Writer.
5. The principal will collaborate with other project team members to gather information, establish timelines and priorities, delineate individual roles in the preparation of specific documents, and ensure the quality of all clinical documents.
6. The principal will maintain the consistency of style, format, and content for clinical documents to ensure adherence to FDA, CTD (ICH), and other regulatory guidelines.
7. The principal will be responsible for appropriate planning and resource allocation for all writing projects.
8. The principal will provide input, when appropriate, for clinical publications.
9. The principal will assist with the integration of clinical trial data and information into concise and uniform reports for poster assembly, slide presentation, journal submission, or non-routine submission to regulatory authorities, using source documents from various sources and assuring a consistent style and approved format.
10. The principal will assist with the circulation of clinical/medical data/information via reports to departmental and Company employees, as directed.
11. The principal will assist with the interaction of data management, biostatistics, and pharmacokinetics management staff (either in-house or vendor) to provide appropriate data output for the timely completion of required responsibilities.
DEPARTMENT SPECIFIC/NONESSENTIAL FUNCTIONS:
1. Will be responsible for insuring the completion and documentation of all clinical writing projects.
2. Will educate self and medical writing group regarding current products, customer needs, and clinical applications.
3. Other duties, as assigned, with or without accommodation.
EXPERIENCE:
Minimum of 4 years experience in the writing of medical or technical documents, including working in a multifunctional team environment. Minimum of 2-3 years managerial experience.
1. Demonstrated leadership and collaboration abilities.
2. Ability to effectively handle conflict through proactive action and direct and timely communication.
3. Demonstrated attention to detail and experience to check behind the scenes to ensure documents contain the appropriate content.
4. Knowledge of FDA pharmaceutical guidelines and Common Technical Document (CTD) format.
5. Strong organizational and planning skills.
6. Excellent interpersonal skills with demonstrated ability to work in a team environment and effectively interact with people at many levels of the organization.
7. Ability to identify inconsistencies between data listings and the output of biostatistics, or of current clinical trial status reports, or other administrative or clinical problems, and to resolve them with minimal supervision.
8. Strong managerial abilities.
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Contact: Rebecca Butler [rbutler@]
XDx, Brisbane CA
JOB DESCRIPTION
I. Specifications
Title: Automation Specialist I
Manager: Associate Director, Automation
FLSA: Exempt
Classification: Regular Full Time
Department: Research and Development
Location: Brisbane, CA
Management: N/A
II. General Description
The Automation Specialist will work in the Automation group validating and supporting liquid handling instruments and real-time PCR instruments for our commercial laboratories. This position will help refine and expand our automated equipment and methodologies. The Automation Specialist will need to write and update validation protocols, maintenance SOPs and contribute to improving automation practices and procedures. He/she will utilize statistical techniques to perform complex data analysis. A successful Automation Specialist will understand projects in the context of the overall process and will be integral to their success by taking a leadership role in providing automation expertise from project conception to its completion.
Responsibilities include, but not necessarily limited to:
• Provide service support for Beckman Coulter liquid handling instruments, including troubleshooting, routine maintenance and calibration
• Provide service support for ABI 7900HT instruments, including troubleshooting, routine maintenance and calibration
• Develop, validate and support automated methodologies and equipment for manufacturing operations
• Expand, refine, and support automated methodologies and equipment in a leading molecular diagnostic laboratory
• Work with XDx scientists designing and automating new technologies
• May act as a mentor to automation associates
• Design and define specifications, write, review, and validate complex liquid handling methods on numerous platforms
• Provide training to users for new methods, new user training, and is able to provide training to entry level Automation Associates
III. Work Environment:
Travel is not a primary aspect of this position although travel may be requested from time to time. An employee in this position may work in an environment, or visit facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the Corporate and/or Plant policies, rules, and regulations in these areas is required.
IV. Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands and fingers, handle or feel, and talk or hear. The employee frequently is required to sit, stand and walk. There will be periods of time during the workday where the employee will be sitting for 3-4 hours in a row. Regular use of hands to operate office equipment and type on the keyboard is required. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. While working in the reference laboratory, incumbents may be exposed to excessive noise, chemicals and solvents, biological agents, mechanical/electrical hazards, and bloodborne pathogens.
V. Qualifications:
• BS in Engineering, Chemistry, or Life Science with a minimum 5-8 years experience programming automated instrumentation.
• Experience working in a regulated laboratory environment. Including the following; design control, performing verification and validation studies and experience with process development.
• Ability and desire to work in a team environment supporting both manufacturing operations and regulated diagnostic laboratories
• Demonstrate working knowledge of scientific principles; strong analytical and troubleshooting skills required
• Excellent verbal and written communication skills required; experience writing Standard Operating Procedures and other technical reports strongly preferred.
• Strong working knowledge of MS Word, Excel, PowerPoint with proficiency in data analyses
• Proven mastery of programming environments and support on numerous instrument platforms (i.e., Beckman, Tecan, Agilent/Velocity 11). This includes the ability to provide advanced technical support and error recovery, as well as, coming up with creative solutions to software or hardware failures.
*****************************************************************************Andrea Fleig from Queen's Medical Center in Honolulu, HI is looking for someone who can consult on the topic of Clinical Research Study Design They conduct different types of research, gastro-interology, infectious disease, trauma, cancer, etc.
Please contact her or pass this to a qualified colleague: afleig@hawaii.edu
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Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
FAX: (510) 235-4482
e-mail: jim@
VP STRATEGIC PLANNING
Job Summary
This position will be relied upon to support the agency’s strategic planning efforts. S/He will work with various teams to ensure deep understanding of our customers in terms of both insight and experience, and then translate that understanding into positioning, branding and strategy. A research and planning background is key – a minimum of 10 years of experience is required. Digital agency experience/understanding is required.
Job Responsibilities
o Drive and own customer understanding, provide consultative services, and execute market research on behalf of the existing or prospective clients.
o Bring creative ideas that meet needs, solve problems and drive the business strategy. Can manage the creative process and facilitate brainstorming. Open to the ideas of others. Can project how potential ideas may play out in the marketplace.
o Conveys thoughts, ideas, feelings and decisions in a clear, concise and appropriate manner. Demonstrates both good verbal and writing skills. Is a good listener and always makes an effort to get to know their audience.
o Creates a plan that organizes and aligns resources in order to accomplish objectives within an established timeline. Handles unanticipated events and situations effectively by having an alternative plan of action. Efficiently manages multiple demands and competing priorities.
o Understands organizational needs, issues and constraints that affect decisions. Can foresee the effects that new events, situations or decisions can have on individuals and groups within the organization.
o Support the agency in maintaining and enhancing overall awareness and credibility of the agency within the industry.
o Understands industry trends and their potential impact on our organization. Maintains a stable of sources for real-time information that can affect our industry and our company. Knows our position in the market place and works to exploit it.
o An ability to get others to understand your ideas, gain support for your decisions and implement your strategies. Influence others to follow you.
o Time out of the office – visits to clients and/or travel ranges from 20 – 40-% depending on project and brand assignments.
Critical Job Dimensions (Indication of level within job family)
▪ Span of Control – Reporting Relationships
o Direct:
▪ Client and brand team support.
o Indirect/Matrix:
▪ Broader agency initiatives.
▪ Financial Impact and Accountability
• Department billability; department budget.
▪ Strategy & Innovation (high, med,, low)
• High – Seeing beyond status quo to develop innovative ways of driving growth in the business.
▪ Client Partnerships
• High – High visibility with client.
▪ Level of Strategic Alliances and business relationships expected to build?
• Client, sister companies & external partners.
▪ Decision Making Impact
• High strategic impact and process design.
Job Requirements
▪ Bachelor’s Degree – Preferred Master or MBA
▪ 10+ years of experience in a relevant field (planning or research)
▪ Preferred psychology or anthropology background
*****************************************************************************Candidates must have prior experience in oncology product management.
Contact:
Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
e-mail: jim@
SENIOR PRODUCT MANAGER In Start Up Company in Bay Area
Company:
An oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing its lead product candidate for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been submitted to the U.S. Food and Drug Administration for CML patients with the Bcr-Abl T315I mutation. The corporate strategy is to commercialize the product independently in North America and to establish commercial partnerships in the rest of the world.
Responsibilities
Based in the San Francisco Bay Area, and reporting to the Director of Marketing, the Senior Product Manager will be responsible for planning and executing the North America oncology marketing strategy. This position will build upon all the key elements of the market plan; product positioning, branding, pricing and promotion/medical education for the CML product launch as well as for other oncology indications in the pipeline.
The position has responsibility for developing and managing the product management function and to work in concert with other functional departments to ensure commercial success for the company’s products and services. The Product Manager will take a leadership role in developing key opinion leaders and will establish relationships with the oncology community at large. In addition, the Product Manager position will assist and support the build out of a Sales and Service capability.
Position, Purpose and Responsibilities
Specifically, the Senior Product Manager will be responsible for and participate in the following activities:
• Utilize their track record of success in pharmaceutical marketing to drive the implementation of the US marketing strategy.
• Strive to set new standards in marketing excellence to ensure the successful launch of the CML product launch.
• Take the lead on the creation of effective material and programs to ensure the effective implementation of the marketing communication efforts.
• Will work in concert with other corporate groups to ensure that commercial success is achieved through effective team work.
Essential Duties and Responsibilities
1. Marketing planning
• Oversee the execution of key elements of the tactical plan
• Take an active role in the strategic planning process and drive the compilation of an effective operation plan to implement the marketing strategy
• Manage spend allocated to key marketing activities against the approved budget
2. External Customer focus
• Help identify, target, establish and foster ethical working relationships with
o KOL’s in CML
o Influential HemOncs in key cancer centers
o Patient Advocacy groups
o External vendors
o Other customer groups identified in the marketing plan
3. Market & Competitor intelligence
• Develop and maintain information systems of secondary market research/data that ensures the business is kept abreast of key changes in the evolving oncology business environment and ensure this information is communicated to relevant people in a timely manner
o Develop and implement the primary marketing research plan to address critical information gaps
4. Internal Customer focus
Field Forces
• Work with the sales and managed care teams to compile a program of support activities and materials and deliver quality outputs on time and in full
Medical & Medical affairs
• Assist with the implementation of the publications plan to ensure integrity of product positioning and key messages
Regulatory
• Understands the code of practice and overall regulatory requirements and their impact on commercial strategy and activities
Clinical
• Support the promotion campaign for the trials program to ensure we can meet our recruitment targets
Manufacturing & Supply
• Optimize the distribution chain for OMAPRO including the scheduling of product demand
Position Requirements
• Bachelor’s degree, preferably in the life sciences. MBA or other advanced degree is desirable
• Minimum of 3-5 years progressive experience in marketing of medical products, preferably to oncology customer groups
• Product launch experience, preferably in the field of oncology.
• Significant experience setting up and implementing marketing plans.
• Experience working with clinicians
• Good conceptual, analytical, problem-solving and organization skills
• Excellent interpersonal, communications and presentation skills
• A reputation of being one of the best at his/her peer level, a well-rounded business executive on the basis of technical competence / intelligence, results, interpersonal skills, and general business acumen
• A reputation for consistently meeting objectives and deadlines
• An action-oriented, “hands-on” individual who enjoys challenge; is capable and dedicated to getting the job done with minimal support and direction; must be a “self-starter” who enjoys the challenges of working in a start-up environment.
• A high energy individual, accustomed to a busy work schedule including extensive travel, and works well under pressure
• An assertive, take-charge, proven manager with a strong results orientation, positive “can-do” attitude and a sense of urgency to get things done.
****************************************************************************See two job opportunities with health care advertising agencies in
the NY/NJ area directly below. The client will not relocate. They're looking for East
Coast candidates only. Health care agency experience is necessary for
consideration.
Interested candidates should forward their resumes to:
Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
FAX: (510) 235-4482
e-mail: jim@
VICE PRESIDENT, GROUP ACCOUNT SUPERVISOR
Reports to: Executive Vice President, Director Account Services or Senior VP Management Supervisor
Department: Account Services
Position Summary:
Oversee all agency activities on assigned business and also handle new business pitches and projects as assigned.
RESPONSIBILITIES OF POSITION
1. • Hire, train, develop and evaluate all levels of account services staff
2. • Fill in/back up staff when open positions exist
3. • Lead and support the development of strategically sound and innovative Communications Plans
4. • Provide strategic leadership and marketing savvy to clients, direct reports and internal teams
5. • Be a proactive champion on behalf of assigned business yet see the big picture
6. • Manage all aspects of assigned business including financial, marketing, staffing, and interpersonal
7. • Analyze assigned business and keep supervisor informed of all issues related to assigned business
8. • Grow assigned business
9. • Monitor all new product and new business opportunities on assigned business and recommend to supervisor how the agency can capitalize on these opportunities
10. • Initiate relationships with all levels at client focusing on senior levels and requesting additional involvement from agency upper management whenever necessary
11. • Handle new business pitches as assigned by upper management
12. • Demonstrate leadership ability by embodying unifying principles, being a good corporate citizen, showing organizational savvy, and being a positive influence and example
13. • Interact with all levels of agency staff with respect, a commitment to teamwork and an awareness of agency resources
14. • Accurately forecast anticipated business
15. • Contribute to creative strategy development on products outside of assigned business
KEY SUCCESS FACTORS (SPECIFIC DURING NEXT 6-12 MONTHS)
1. • Ability to articulate strategic marketing concepts and lead strategic discussions/meetings
2. • Ability to successfully manage the assigned business including filling in when open positions exist
3. • Maintenance of key relationships with clients and internal staff
4. • Ability to hire, train, develop and evaluate account services staff
5. • Adherence to agency unifying principles
6. • Thorough understanding of assigned clients' business
7. • Ability to manage agency resources and finances on assigned business (staffing, forecasting, write offs, transfers and receivables)
8. • Ability to anticipate challenges and provide solutions
9. • Ability to take the lead in initiating relationships with senior level clients
ATTRIBUTES/SKILLS REQUIRED/SOUGHT
1. • Excellent verbal and written communication skills
2. • Initiative on behalf of clients
3. • Analytical and problem solving ability
4. • Strong leadership skills
5. • Excellent interpersonal skills
6. • Strong strategic marketing skills
7. • Excellent understanding of agency financial issues
8. • Ability to manage many priorities
MINIMUM REQUIREMENTS
Qualifying for this position normally requires the following:
1. • Sales experience
2. • Bachelor’s Degree
3. • 7 years agency experience
4. • Product management experience preferred
5. • 3 years professional level management
6. • Variety of therapeutic area experience
********************************************************
Kanchana Udani.
Infobahn Softworld Inc
recruit@
408-855-9616x103
Fax 408-855-9490
efax 408-521-0805
Client Genentech
Start 02/15/2010
End 05/31/2010
Description:
Department CIT Direct-Prod Dev
Job Category SQA
Job Code SQA Engineer
Job Title SQA Engineer
Duties Responsible for developing test plans, test protocols, scenarios and scripts to test business critical applications in Development. Applies software testing principals and test case design concepts to complete these deliverables in different project phases, e.g. for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The main focus is on testing applications designed for the processing and trasnmittal of files between servers. Makes sure that applicable regulations, guidelines and internal procedures related to quality assurance (QA) and validation are followed and applied. Works with IT project teams, database administrators, validation and QA staff.
Skills Formal technical training in software development life-cycle (SDLC) methodologies, software testing methodology, and familiarity with software testing tools are a must. A good understanding of the principles of software validation in regulated industries is a plus, including 21 CFR Part 11, PDA 18, related FDA guidelines and regulations, as well as ICH GCP guidelines. Good interpersonal and communication skills and the ability to produce required validation documents with minimal supervision are highly desirable. Experience in the biotech or pharmaceutical industry is desired. Technical skills should include good knowledge of Oracle databases, SQL language.
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Jobs That Crossed My Desk Through Feb. 7, 2010
TO APPLY: email resume in strict confidence to: Deborah Kaufman, e: erxhealthcare@; and check out our website at: healthcare-
TITLE: Global Product Marketing Manager/Director
LOCATION: Northeast USA
SECTOR EXPERIENCE: Cardiac Sector Medical Device [note, CRDM and/or electrophysiology experience is especially attractive]
YEARS OF EXPERIENCE: 7-10 years
REPORTS TO: VP-Global Marketing
QUALIFICATIONS:
- Masters Degree/MBA preferred; minimum of 7-10 years of progressively responsible medical device marketing experience; PMA and IDE experience and a solid understanding of the regulatory requirements required; cardiac-sector marketing/product management experience a must. Medical device sales experience preferred.
- Strong analytical, strategic thinking and problem solving skills; strong verbal and written communication skills, and well-honed interpersonal and leadership skills are required.
- Ability to interpret and convey clinical data required.
- Independent thinking; self-starter with a high level of initiative and the ability to instill confidence with physician, customers, and key opinion leaders (KOLs) audiences
- Must be an effective team leader in a fast paced, high visibility environment.
KEY RESPONSIBILITIES:
- Manage the product marketing effort and product management team [note: This position
will have management responsibility over department Product Managers]
- Drive the development and execution of Market and Product strategies and tactical plans.
- Actively support the worldwide selling efforts, including close collaboration with the field sales force.
- Provide product, competitive, and clinical data analyses to global sales force.
- Create comprehensive marketing collateral based on clinical indication driven market segments, including design and execution of messaging, promotional materials, sales tools, and proof sources.
- Responsible for managing new product planning, including collaborating with product development teams to ensure process is focused on customer needs, minimizing time-to-market.
- Design and implement promotional programs to maximize impact of sales efforts.
- Manage the analysis of customer satisfaction data and apply such data to improve marketing and product strategies.
- Foster relationships with key clinicians/organizations within the industry.
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has just launched a new page offering useful tips for writing CVs. Pls visit:
uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, also has a click-by-state job bulletin (biotech-pharma-jobs) for employers/recruiters and job-seekers to post and find pharma jobs, biotech jobs, and other life science jobs for free. The following is a list of recent job postings:
Clinical Science Consultant with Boehringer IL
Clinical Science Consultant with Boehringer LA
Clinical Science Consultant with Boehringer TX
Clinical Science Consultant with Boehringer GA
Clinical Science Consultant with Boehringer CA
Clinical Science Consultant with Boehringer VA
Clinical Science Consultant with Boehringer GA
Project Manager with Boehringer OH
Senior Product Manager, Cancer NJ
Business Operations Associate NJ
Senior CRA – Medical Device CA
Technical Services Specialist CA
Product Chemist – Polymers CA
Immunology Pharmacist Manager NJ and other states
Equipment Validation Consultants Boston, MA
Technical Writer CA
Pls go to our job bulletin biotech-pharma-jobs. It’s easy to use the View All Jobs function to find jobs. Pls read the job descriptions carefully. Pls check that there is a reasonable fit and then follow the specified instructions to apply. Pls be sure to mention that you found the job(s) at .
Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
****************************************************************************
Contact
Dr. Moshe Sarfaty
408-464-4051
lsbiopath@ or m.sarfaty@
Bio-medical engineer/scientist with background in electrophysiology who will lead research and clinical studies in the field of dielectric characterization of tissue.
****************************************************************************
We are pretty urgently looking for a few people to help our client with the in-house consulting project in East Bay. Specifically, extensive monitoring, TMF review and/or audit experience, will be required. If you are interested and for more information, please send you CV to info@osmos.us
All applications will be considered in strict confidentiality
Thank you!
*****************************************************************
Charlie Cunneff
Riverstone Search, Ltd.
719-302-0600 Office
719-331-4862 Mobile
in/ccunneff
I'm searching for a candidate to fill a clinical marketing manager position for a client in the Bay area .
Here are some key points about the search if you would know anybody.
• Someone with an RN would be nice to have
• Must have experience working within the medical device sector, prefer endovascular/neurovascular or cardiovascular device background
• A background can include either someone who worked extensively in clinical research/clinical education/clinical training or someone who moved into marketing and has done actual "clinical marketing" type activities.
• We will consider a more junior up and coming candidate or a more seasoned manager level.
• Travel with be fairly extensive. 40-60%
I can provide more information, but at this point just trying to get the word out.
*****************************************************************
Jobs That Crossed My Desk Through Jan. 31, 2010
Contact:
Please send resume to: RLP@.
Robert Posluszny (Bob Poz)
Managing DirectorJudge, Inc. Pharmaceutical Division
Phone: 732-346-9100 x 4212
Toll free: 888-228-7165 x 4212
Fax: 732-497-4213
RLP@
Director/Senior Director, Medical Writing
Massachusetts
The Director/Senior Director will be responsible for managing and coordinating all medical writing activities Research and Development including protocols, clinical study reports, investigator brochures, IND and NDA annual reports, and any other document involved in a regulatory submission. The Director/Senior Director will be responsible for line management of all staff within the Medical Writing function.
Functions:
• Oversee generation of the clinical portion of all IND filings
• Oversee production of Integrated Clinical Study Reports, Integrated summaries of Safety and Efficacy, Annual IND reports, IND safety reports to support NDAs
• Maintain and develop protocol and clinical reporting templates and any other SOPs associated with the medical writing function.
• Oversee Investigator Brochure templates and ensure Investigator brochures are produced in accordance with regulatory and corporate policies.
• Manage consistency of style format and content for all documents required for international regulatory submissions.
• Serve as primary liaison between all departments in Research and Development for the production of regulatory documents.
• Mentor and manage all medical writing staff.
• Develop functional structure and job descriptions to allow growth and development opportunities for Medical writing staff Ensure that all documents produced by the Medical Writing Department have undergone appropriate Quality control and consistency checks to meet internal standards
Qualifications:
• Experience required: BS w/ 5 or more Years experience, at least 2 years management experience
• Knowledge & skills
• The position requires an individual with excellent organizational skills
• The individual must:
• Be highly self-motivated.
• Be a strong team player and provide a vision to develop the medical writing group.
• Demonstrate the ability to manage, mentor and train individuals.
• Possess a fundamental working knowledge of ICH, FDA and EMEA GCPs
*****************************************************************************
Contact:
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct Line: (781) 496-3133
Direct Fax: (866) 855-5872
Email: JLeveille@
100 Unicorn Park Drive
Woburn, MA 01801
Senior Scientific Medical Writer, Contract- Montville, NJ
Length of Assignment:
6 mos - 1 year, contract to perm
Start Date: As soon as possible
Location: Montville NJ, on site
Client:
Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company who's purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
Position:
The Senior Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. This person will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
Participate in the development of the strategy of the submission and the label and carry those key messages into regulatory documents
Assure quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews
Required Skills:
• BS or equivalent with 6 years experience in a scientific discipline and a minimum of 6 years in medical writing, OR
• MS, PhD, or equivalent with a minimum of 5 years of previous industry experience and 3 years of medical writing experience
AND
• Excellent written and oral communication (English)
• Demonstrated working knowledge of scientific principles
• Familiarity with all phases of medical research and ability to learn new medical concepts quickly
• Familiarity with statistics and experimental design
• Ability to summarize complex data and identify relationships
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Contact:
Send resumes to resumes@.
Technical Writer, Contract – San Jose, CA
Full-time, contract position for 3-5 months, developing user documentation for lab analyzer equipment.
Location: Onsite required in San Jose, CA. CANDIDATES MUST BE LOCAL.
Requirements:
• Expert FrameMaker skills.
• 3+ years experience writing about lab analyzers or some other biotech equipment
• 7+ years of Technical Writing experience
• Able to work independently
• Familiarity with style guides
• Work closely with cross-functional teams
• Communicate status, issues, and risks to project stakeholders
• Ability to meet deliverables
Rate: $48.50 on 1099
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Contact:
Matt Soloperto | Consultant
Life Science Division
The Bowdoin Group |
Direct: (781)-263-5205
msoloperto@
Senior Manager/Associate Director, Medical Writing
Cambridge, MA
Relocation is available for the right candidate.
Responsibilities:
• Responsibilities will include the building and management of a medical writing editing, and
Four years or more of direct biotechnology or pharmaceutical industry
publishing group. Major focus will be the management of operations involving production of clinical documents, regulatory documents, presentation materials, and publications. Will work closely with biology, medical affairs, regulatory affairs, and the commercial group. Also will be responsible for the development of processes, formats and guidelines for clinical documentation. Will manage other medical writers and medical personnel. May write, review and/or edit documents ensuring the integration of scientific, medical and regulatory input. Ensures compliance with current regulations and requirements. May oversee and/or evaluate external consultant writers. Ensures effective planning and management of timelines for all aspects of technical documents. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Additional responsibilities for this individual will include coordination of medical writing activities across departments such as coordination of required reviews and reviewers, incorporation of reviewer comments, finalization of documents, including proofing, editing, reviewing, and revising as necessary.
Technical Skills:
• Ability to recruit and manage contract medical writers and/or internal medical writing team
• Outstanding writing skills coupled with a comprehensive knowledge of the drug development process and regulatory guidelines are key, along with careful attention to detail
• Excellent interpersonal and communication skills are essential
• Facility with various computer software applications and formats
• Experience in oncology preferred
Job Description:
This individual will build and manage a team of contract medical writers and independently contribute by writing, reviewing, revising and formatting clinical and other regulatory documents and publications, such as clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, other regulatory submissions, abstracts, manuscripts, reviews, posters, and slide decks for internal and external use. In addition, the individual will perform quality control review of clinical and regulatory and publication documents. The individual will represent Medical Writing on project teams, and as such advise the teams on content and format requirements for various documents as well as coordinate writing activities for clinical development programs (eg, timelines and review/revision responsibilities) with the project teams. Collaboration with the biology group, program management team, the regulatory group, and the commercial/marketing group will be essential.
The individual will remain informed of the latest professional, technological, and regulatory developments in medical writing as well as maintain knowledge of product areas, current trends, and current literature.
Requirements:
A minimum of BA or BS degree. Advanced scientific degree in the life sciences preferred (MS or PhD)
• Experience as a Medical Writer
• Experience managing and preferably building a medical writing team
• Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses
• Ability to work well both independently, as well as on a team, with strong interpersonal skills
• Initiative and the ability to handle a variety of projects simultaneously and productively with minimal supervision
****************************************************************************
Job Title: Quality Assurance Device Manager, MAP Pharmaceuticals
Reports To: Director, Quality Systems
Department: Quality
For immediate consideration forward Resume to elly.grimaldi@
SUMMARY: The Quality Assurance Device Manager will be responsible for providing quality support to engineering for Pharmaceutical and Medical Device products during the development and manufacturing stages. The position is the primary quality signatory for design control documents.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides guidance to others in the areas of Quality Systems Regulations and quality Design Control requirements.
• Provides leadership for continuous improvement activities.
• Implements tactical plans with little or no supervision.
• Teams with manufacturing and R&D engineers to develop procedures that ensure appropriate quality and compliance.
• Demonstrates quality assertiveness and independently represents the quality function at decision making meetings.
• Performs statistical analysis to evaluate trends and to assure manufacturing process capability meets process specifications.
• Develops and reports quarterly quality key performance indicator metrics to the management team.
• Takes a lead role to facilitate and support the risk analysis/FMEA/hazard analysis process, risk management activities, quality evaluation of design controls, quality master plans, validations, capability studies, investigations, CAPA, and complaints.
• Collaborates with the compliance quality group to audit suppliers for design control.
• Performs quality control review of documents against relevant source documents.
• Authors standard operating procedures (SOPs) and change controls.
• Ensures that master drawing files and history files are accurate and current.
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and seven years of related experience; or,
• MS/MA degree in related discipline and five years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
Experience:
• Typically requires a minimum of eight years of related experience and/or combination of experience and education/training.
• Degree in a chemical, biological or physical science area and at least five (5) years quality experience in medical device industry.
Experience:
• CQE and green/black black Six Sigma certification a plus.
• Participation with inspectors during regulatory inspections
Knowledge/Skills/Abilities:
• Experienced with design material engineering and ability to make risk based decisions to support quality compliance and customer value after soliciting feedback.
• Knowledgeable of the regulatory and quality requirements for the manufacture of medical devices as required for FDA or international regulatory agency approval (E.g. FDA part 820 QSR, ISO 13485:2003; 14971, cGMPs, FDA design control requirements, GAMP4).
• Proficiency with MS office, MS Access, MS Visio, SPC tools (e.g., Minitab, jmp) and ability to use enterprise software.
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__________________________________________________________________________
Job Title: QA/Documentation Control NDA Control Specialist
Reports To: Director, Quality Systems
Department: Quality
Resume should be forwarded to elly.grimaldi@
SUMMARY: Under general direction, performs QA/NDA Control tasks in support of Pre-approval Inspection (PAI) Audits/New Drug Application (NDA) submission activities. Responsible for implementing all aspects of the Company’s QA/NDA control programs with respect to conformance to the regulatory and quality requirements for the manufacture of pharmaceuticals and medical devices as required for Food and Drug Administration (FDA) and international regulatory agency approval. All activities and job functions must be performed in accordance with the Company’s policies and procedures for quality, regulatory compliance and safety.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provides support for PAI/NDA submission activities.
Identifies and locates documents required for NDA submission, ensuring completion and accuracy.
Prepares documents for formatting and merging for NDA submission.
Prepares document requests during regulatory inspections.
Assists in the creation, maintenance and administration of all Document Control procedures that support PAI/NDA submission activities.
Assists in the creation, maintenance and administrations of all Document Control logs and databases to ensure they reflect accurate and current information as they relate to PAI/NDA.
Assigns Document Numbers to create new documents.
Implements file naming conventions and standards for consistent file names and file structure hierarchies.
Performs duties in support of established records management procedures, including scanning and logging records and storing records in offsite storage.
Provides document control assistance and support to the user community as required.
Reviews change control packages for correctness and completeness.
Tracks outstanding Change Control Requests.
Interacts with business partners within a team setting by providing technical solutions to QA/NDA Document Control issues.
Conducts QA/NDA document control training.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and one year of related experience; or,
• MS/MA degree in related discipline.
• May require certification in assigned area.
Experience:
• Typically requires a minimum of five years of related experience and/or combination of experience and education/training.
Send resume to : Career Opportunities or e-mail resume to: [pic]elly.grimaldi@
MAP Pharmaceuticals, Inc.
2400 Bayshore Parkway, Suite 200
Mountain View, CA 94043
*****************************************************************************************************************************
Ten positions were posted in January on CACO Free Job Links website (). See details for those positions at site. Note all jobs are Bay Area except for Allergan.
Employer Position
Nektar Therapeutics Sr. Research Associate (DMPK)
Limerick Biopharma, Inc Sr. Research Associate/Research Scientist, Bioanalysis/DMPK
SRI International Senior Research Associate - Immunology & Inflammation
Stiefel, a GSK Company Chemist I-II (Temporary 6-9 mos)
ADDS QA & QC Manager
ADDS Senior Research Associate
Depomed Scientist III Quality Assurance
Allergan Director, Analytical Sciences
Allergan Director, Pharmaceutical Analysis-Method Validation
Allergan Sr. Scientist Analytical Development-Pharmaceutical Sciences
____________________________________________________________________________
For further details please contact:
Rose Mortilla
YES Partners
global executive search
tel +1 (650) 726-8733 x703
rose@
YES Partners is an international retained Executive Search Firm based in the Silicon Valley, adding value to companies by finding exceptional executives they otherwise don’t have access to.
Director/VP of Engineering – Medical Imaging (posted 2010-01-11)
client is an established company.
The Director of Engineering is responsible for all phases of product development, product design and engineering support for existing products.
This position oversees chip design, electrical engineering, software development, mechanical engineering, product design, product line maintenance engineering and an effective interface between Engineering and the manufacturing and marketing departments.
Reports To
• President/CEO
Responsibilities Include But Are Not Limited To
• Work effectively with marketing and senior management to define the product roadmap and engineering priorities
• Manage engineering development projects to ensure high-quality innovative products are continually developed on schedule and within budget.
• Implement appropriate engineering processes, documentation and management disciplines to ensure reliability, efficiency and innovation in product design.
• Continually explore ways to design innovation and technological superiority into the products.
Periodically observe clinical procedures in which digital imaging technologies are used in order to understand first-hand the needs of customers, and to ensure that all products meet or exceed customer expectations.
Provide timely and effective engineering support to the Technical Suppor
• Team as well as the Marketing and Manufacturing Departments.
• Ensure that all processes and product designs are in full compliance with ISO 9001:2000, ISO 13485:2003, and all FDA, MDD, CMDR and state regulatory requirements.
• Develop annual engineering budget and maintain expenses within budgetary guidelines.
Job Requirements
• BS Degree in software design, electrical or mechanical engineering, or imaging sciences required.
• Masters in electrical engineering or software design preferred.
• Minimum of ten years experience in the development of high technology products with a track record of meeting deadlines on time and on budget.
• Minimum of three years experience managing engineering professionals and bringing innovative products to market.
• Excellent management skills with the ability to pull a team together and consistently produce optimal results.
• Proven track record of establishing and maintaining comprehensive document controls.
• Experience in developing and/or working with digital imaging equipment and radiographic sensors strongly desired.
• Comprehensive knowledge of FDA regulatory processes for Class II medical devises preferred.
• Strong communication skills, both oral and written.
• Highly motivated self starter, organized, disciplined, results-oriented.
• Strong work ethic. Hands-on manager who leads by example.
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has just launched a new page offering useful tips for writing CVs. Pls visit:
uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, also has a click-by-state job bulletin (biotech-pharma-jobs) for employers/recruiters and job-seekers to post and find pharma jobs, biotech jobs, and other life science jobs for free. The following is a list of recent job postings:
Project Manager with Boehringer OH
Senior Product Manager, Cancer NJ
Business Operations Associate NJ
Senior CRA – Medical Device CA
Technical Services Specialist CA
Product Chemist – Polymers CA
Immunology Pharmacist Manager NJ and other states
Equipment Validation Consultants Boston, MA
Technical Writer CA
Pls go to our job bulletin biotech-pharma-jobs. It’s easy to use the View All Jobs function to find jobs. Pls read the job descriptions carefully. Pls check that there is a reasonable fit and then follow the specified instructions to apply. Pls be sure to mention that you found the job(s) at .
Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
*****************************************************************************
Please only contact me if you’re qualified and I’ll pass on your resume to my friend:
Audrey Erbes
audreyerbes@
A friend of mine is looking for a "seasoned/experienced person. Not a beginner” who wants full time global marketing job in metro NYC with med device company. Key points:
1) Medical device product/company
2) Oncology - radiology
3) Requires someone with international marketing product management experience
4) Grasp of cross-functional interactions
5) Know-how about distribution channels
6) Interactions with clinical, gov't agencies, medical association
7) Extensive international travel required
*************************************************************************************************
Jarboe and Associates
JanetJarboe@
(OFFICE) 970-686-5899
(MOBILE)
970-689-2962
Research Associate /
Senior Associate, Target Function - MAb Assays – S California
The qualified candidate will be responsible for in vitro target validation activities and monoclonal
antibody (MAb) screening. Characterization and functional validation of MAbs in a variety of cancer relevant cell-based in vitro assays will be a major emphasis. The position involves validation and characterization of synthetic siRNAs and lentiviral shRNAs, development of in vitro cell-based assays, immunological techniques including FACS, immunofluorescence, immunoprecipitation & Western blotting, and extensive work in intracellular signal transduction and molecular pathways. In particular, the incumbent will use target silencing techniques (RNAi) in endogenously expressing cell models, and recombinant target expression in heterologous systems, to identify target-specific cancer phenotypes. Additionally, the candidate will be
responsible for discovery of the molecular mechanisms involved in these phenotypes. The candidate will also be responsible for mammalian cell tissue culture work and will provide general lab support functions.
Position Requirements: The position requires a BS or MS in Biology or a related field with a minimum 3 years of practical experience in a research laboratory in the required activities. Industry experience and previous work in biochemical, immunological, cell culture and cell-based techniques are essential. Excellent verbal and
communication skills and the ability to work both independently and in a team environment are required.
____________________________________________________________________________________
Senior Research Associate, In vivo Validation – S California
The qualified candidate will join our in vivo team to evaluate the functions of novel cancer targets
and determine the efficacy of therapeutic monoclonal antibodies and antibody drug conjugates in mouse models of human cancer. Responsibilities include constructing subcutaneous, orthotopic and other types of tumor xenograft models, administering therapeutic agents through different routes (including
intraperitoneal, intravenous, oral, etc), monitoring effects on tumor growth, metastasis, survival and overall animal health. The candidate shall also perform in vivo studies to evaluate surrogate biomarkers and mechanisms of action for our therapeutic antibodies. In addition, the successful candidate will participate in the generation and characterization of new human cancer xenografts derived from patient specimens and determining appropriate conditions for their growth both in vivo and in vitro. The candidate will aid
in planning and organizing daily tasks within the group. The position shall interact with multiple research teams and present research data to team members and in scientific lab meetings.
Position Requirements:
The ideal candidate should have a MS in biological sciences with a minimum of 5 years experience in
biological research, preferably in an industry setting. Previous experience in handling research rodents, especially immunodeficient mice, is absolutely required. Experiences in pre-clinical validation of cancer therapeutics using xenograft models, performing microsurgical procedures in rodents, xenograft
tumor characterization and mammalian cell culture are highly desired. We are seeking a flexible, enthusiastic individual with good organizational and communication skills and the desire to work in a dynamic team environment.
_____________________________________________________________________________
Research Associate, Target Discovery – S California
We are seeking a highly motivated individual with expertise in molecular biology to join our Target
Discovery Team. The successful candidate will have microarray analysis and qPCR experience preferably in industrial setting. The ability to reliably handle and process precious and limited specimens is essential.
Responsibilities include basic molecular biology, RNA isolation, cDNA synthesis, microarray chip
analysis, data processing, primer design, qPCR expression profiling, as well as SNP and variant characterization. In addition, the candidate will be involved in Southern blot and Northern blot analysis
Position Requirements:
The ideal candidate will have a M.S. or B.S. in Molecular Biology or related field, with preferably
a minimum of three (3) years of relevant experience in industry. Experience in microarray systems, data analysis, RNA isolation, and real-time PCR is required. Excellent verbal and communication skills, as well as the ability to work in a team environment are essential.
_____________________________________________________________________________________
Research Associate, Cell Line Development – S California
We are seeking a highly motivated individual with expertise in mammalian cell culture to join our Cell
Line Development Team. The successful candidate will have cell culture and cell line development experience preferably in industrial setting.
Responsibilities include basic mammalian cell culture, plasmid transfection/selection and cell
cloning. In addition, the candidate will be involved in antibody characterization by various techniques such as ELISA, SDS-PAGE, and western blotting.
Position Requirements: The ideal candidate will have a M.S. or B.S. in Molecular Biology or related field, with preferably a minimum of three (3) years of relevant experience in industry. Experience in antibody expression systems, production cell line generation, and antibody characterization is required. Excellent verbal and communication skills, as well as the ability to work in a team environment are essential.
_________________________________________________________________________________
Research Associate, Translational Research – S California
Key responsibilities include investigating the mechanism of actions of oncology targets and antibody
therapeutics with the purpose of guiding clinical studies by providing strategies for patient selection, selecting dose level and schedule, and selection of appropriate combination partners. As part of a team, the candidate
will use in vitro cell and molecular biology techniques to explore the biology of cancer targets including their signal transduction pathways, mechanisms of action, structure/function relationship, and drug sensitivity/resistance. The candidate will be responsible for design, implementation, and analysis of
experiments as well as both written and oral communication of results and conclusions to the team.
Position Requirements: Candidate consideration requires a BS/MS in molecular and cellular biology or similar
field with a minimum of 3 years of relevant laboratory experience. Industrial experience in Oncology drug discovery is preferred. Successful candidates will have strong written and oral communication skills and be self-motivated.
________________________________________________________________________
Sr. Scientist/Scientist-Preclinical Bio-Imaging – S. California
We are seeking a hands-on scientist to direct internal efforts aimed at developing preclinical Bio-Imaging capabilities. The qualified candidate will establish, manage and maintain new Bio-Imaging facility. He/she will design, execute, and interpret in vivo studies with antibody therapeutics that employ imaging modalities
including micro PET/CT in a preclinical, translational setting. The qualified candidate will establish protocols for using bioimaging instruments and be responsible for managing the equipment and training and supervising users engaged in radiopharmaceutical research. The successful applicant will be expected to provide research leadership, technical expertise, and mentorship in the broad area of bio-imaging. The successful candidate will also play an integral role in a cross-disciplinary team of scientists involved in the discovery and evaluation of biomarkers and mechanism of action for emerging antibody therapeutics for oncology. The position offers a unique opportunity for a talented scientist to work in a dynamic and innovative environment and to
develop their career at the interface of basic research and drug discovery.
Position Requirements:
• PhD with a background in radiology, cancer or cell biology that includes analyzing and interpreting
imaging data
• Minimum of 4-5 years of industrial or academic experience in relevant fields
• Research experience in small animal imaging, managing relevant equipment and interpreting
radiopharmaceutical experiments is critical
• Experience with use of in vivo models to explore PK, PD and efficacy and their relationship with
biomarker expression is highly desirable
• A proven publication record is desirable
• Ability to take charge and drive projects to completion
• Effective interpersonal and technical communication skills with ability to report and communicate study outcomes to project team(s)
• Ability to work in a team oriented environment and oversee portions of studies performed by other
groups or departments
• Understanding of ALAAC accreditation and IACUC protocols is highly desirable.
____________________________________________________________________________
Senior Scientist /
Scientist, Cell Line Development – S. California
We are seeking a highly
motivated scientist with strong background in cell and molecular biology with
cell line & bioprocess development experience in a biopharmaceutical
organization. The position involves CHO cell line development of antibody
product candidates, including vector development, transfection/selection, clone
screening, clone selection and antibody characterization. The successful
candidate is expected to work creatively, independently and collaboratively in
a dynamic team environment
Responsibilities
include basic mammalian cell culture, plasmid transfection/selection and cell
cloning as well as antibody characterization by various techniques such as
ELISA, SDS-PAGE, and western blotting. In addition, the candidate will be
involved in interfacing with scientists in process development and
manufacturing areas, writing reports and timely communicating results to other
members of multidisciplinary teams.
Position Requirements: The successful candidate will have a
PhD in biotechnology, cell biology, biochemistry or related discipline with
minimum 5 years of relevant industry experience. Other required experience
includes expertise in a broad range of molecular and cellular techniques
surrounding aspects of cell culture, vector development and expression
technologies, cell line development, and cell banking. Experience with
management of research associates and demonstrated leadership is preferred.
Excellent verbal and communication skills, as well as the ability to work in a
team environment are essential.
____________________________________________________________________
Formulation
Development Scientist – S. California
The successful
candidate will play a key role in developing and implementing formulations for
the development products of company’s anti-cancer monoclonal antibody. The
scientist will interact with the functional groups in the Development, QA/QC,
and CMC teams to define and oversee strategy for formulation development.
Essential responsibilities include but are not limited to:
• Lead the design and
execution of experimental programs to develop phase I and II clinical
formulations
• Supervise pre-formulation activities, such as (pH-dependent) solubility, stability, and
excipient compatibility testing of new products
• Develop formulations of adequate stability for research, pharmacology, toxicology and early clinical studies
• Characterize prototype formulations and support development of corresponding analytical
methods
• Develop and scale-up of formulation processes using DOE.
• Maintain a current awareness of formulation and delivery technologies.
• Maintain a current awareness of and enforce applicable government regulatory, safety, occupational health, and environmental requirements.
• Work closely with other Research and Development teams, actively supporting testing of new drug formulations at various stages of development, meeting project timelines and goals
• Contribute to CMC sections for regulatory filings.
Position Requirements: • Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Experience in the pharmaceutical industry is preferred in formulation development or related
biochemistry related areas of development (e.g. purification, stability,analytical).
• Experience working with monoclonal antibodies and exposure to early phase formulation development activities
• Experience with IV formulations as well as formulation development for poorly soluble compounds would be desirable.
• Proven experience managing the scale-up and manufacturing of parenteral dosage forms
• Proven ability to apply the principles of the basic sciences, such as physical and organic
chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
_____________________________________________________________________
Research Scientist/Senior Research Scientist, Translational Research – S. California
Key responsibilities include investigating the mechanism of actions of company’s oncology targets and antibody therapeutics with the purpose of guiding clinical studies by providing strategies for patient selection, selecting dose level and schedule, and selection of appropriate combination partners. The qualified candidate will use in vitro cell-based platforms to explore the biology of cancer targets including their signal transduction pathways, mechanisms of action, structure/function relationship, and drug sensitivity/resistance. The candidate will be responsible for identifying molecular markers of sensitivity/resistance, signal transduction processes, and interactions between potential combination partners to guide preclinical and clinical studies. The incumbent will join an interdisciplinary team of scientists and research staff, developing novel anti-tumor antibody therapeutics. The position will involve both management and bench-level activities, and will collaborate with other preclinical scientists in diverse fields of drug discovery as well as medical oncologists directing clinical studies.
Position Requirements:
Candidate consideration requires a Ph.D. in molecular and cellular biology or similar field with a minimum of 6 years of post-doctoral experience. Industrial experience in Oncology drug discovery and experience managing research associates is highly preferred. Successful candidates will have strong written and oral communication skills, be self-motivated, demonstrate leadership and possess an exemplary record of research, as evidenced by publications and patents. Developmental opportunities include leading projects for therapeutic
antibody discovery, building new technology platforms, and team leadership.
_____________________________________________________________________________
Target Discovery – S. California
We are seeking a highly motivated scientist with strong background in molecular biology or related field with microarray chip, bioinformatics and cancer biology experience in a biopharmaceutical organization. The position involves target discovery and biomarker identification for therapeutic antibody development, including experimental design, data mining, target review, expression profile validation and target candidate selection. The successful candidate is expected to work creatively, independently and collaboratively in
a dynamic team environment.
Responsibilities include microarray chip experimental design, specimen processing, data mining, gene characterization at the genomic level, and expression profiling by qPCR. The position requires application of various molecular biology techniques, cell signaling, protein biochemistry and data analysis skills to design, execute and interpret experiments. In addition, the candidate will be involved in interfacing with scientists within cancer research and antibody development areas, writing reports and timely communicating results to other members of multidisciplinary teams.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery,
biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
_____________________________________________________________________________________
Senior Director,
Quality Assurance - N. California
Seasoned Quality Assurance Manager/Executive with experience in global manufacturing operations
and in-depth knowledge of regulatory/compliance requirements. This role will be responsible for
administrating standards of quality practices that encompass an integrated multi-national organization of external CMO’s and internal manufacturing locations. This Quality professional will need to interact with all levels of the organization on global policy and guidance for the manufacturing and global distribution of
Biopharmaceutical products. The candidate will need to balance the requirements from a quality perspective of manufacturing internal produced products versus the utilization of a broad
portfolio of third party contract manufacturers. International expertise of GMP’s across multiple business functions through harmonization of procedures and best practices. 8-10 years, NDA approval and commercial scale, International expertise of GMP's.
_____________________________________________________________________________
Associate Director -
CMC Regulatory Affairs- N. California
BA degree in a relevant discipline and minimum 10 years of relevant experience in regulatory affairs.
An advanced degree is desirable.
Previous people management experience and direct experience working with Regulatory Authorities.
Experience representing Regulatory Affairs on project teams is mandatory.
Excellent verbal, written, negotiation and interpersonal communication skills are required.
Must have an extensive knowledge of regulatory requirements,including ICH requirements.
_____________________________________________________________________________
Sr. Principal Scientist, Pharmacology
Assumes technical responsibility for all assigned non-clinical pharmacology activities pertaining to drug discovery, drug development, regulatory, and marketing commitments.
Duties and Responsibilities:
1. Participate in problem solving in pharmacology issues.
2. Prepare regulatory submissions for pharmacology to include Investigators Brochure, IND and NDA.
3. Oversee administrative and technical aspects of nonclinical studies conducted at contract laboratories.
4. Design and conduct nonclinical studies to support regulatory submissions worldwide as well as non-standard study designs for label expansion and marketing.
5. Responsible for analysis and interpretation of nonclinical data and its potential relevance to the clinic (safety/efficacy).
6. Serves as the pharmacology representative on project teams.
7. Reviews and provides technical evaluation of pharmacology data for in-licensing opportunities.
8. Responsible for activities related to the scientific communication plan in support of commercialization messaging.
9. Design and conduct early stage nonclinical exploratory or pre-IND studies to support drug discovery.
Additional Responsibilities:
1. Publish pharmacology data for marketed and drugs in development.
2. Participate in the review and writing of SOP's.
3. Perform quality control checks on protocols, reports and regulatory submissions for pharmacology.
4. Conduct computerized literature searches for publications on assigned topics.
Requirements:
Ph.D. or equivalent required.
10+ years of relevant experience required.
Must have external recognition of expertise in terms of peer-reviewed publications, invitations to speak at scientific symposiums, and trade association committee assignments.
Knowledge, Skills, and Abilities:
1. Excellent written and oral communication skills.
2. Knowledgeable in GLP and regulatory guidelines (FDA/ICH) regarding pharmaceutical development.
3. Working knowledge of Microsoft Office products (or equivalent) and internet navigation.
4. Ability to handle workload associated with multiple projects.
_____________________________________________________________________________
Sr Scientist III, Biodisposition
The incumbent will design pharmacokinetic and drug disposition studies in accordance with all applicable regulatory guidelines. They will also initiate and manage pharmacokinetic studies placed at external contract research organizations. Duties include performing pharmacokinetic data analyses, preparing technical documents of the highest quality to report the results of such studies, and ensuring that all applicable policies and procedures are followed in conduct of studies and preparation of technical documents.
Minimum Qualifications:
- M.S. in an appropriate discipline (e.g. Pharmacokinetics, Pharmacology,
Biochemistry, Chemistry) with 9-10 years industry experience.
- Ph.D. in an appropriate discipline (e.g. Pharmacokinetics, Pharmacology, Biochemistry, Chemistry) with usually 6 years industry experience.
- Demonstrated expertise in the design and conduct of pharmacokinetic and drug disposition studies.
_________________________________________________________________________________
Manager, Biodisposition
Manager, in its Department of Pharmacokinetics and Drug Metabolism, to plan and manage pharmacokinetic and drug disposition studies to support marketing approvals of products by regulatory agencies
world-wide. They will ensure that all studies and their associated activities are conducted in compliance with all applicable policies and procedures.
Job Responsibilities:key responsibilities: writing, submissions, regulatory work
- Design pharmacokinetic and drug disposition studies in accordance with regulatory guidelines.
- Effectively manage the toxicokinetic program through collaborative relationships with Bioanalytical, Toxicology and Safety Pharmacology units.
- Prepare high-quality technical documents and appropriate sections of drug approval applications.
- Represent the Pharmacokinetic/Drug Metabolism department on R&D drug development teams.
- Participate in and contribute to departmental strategic plans, budgets, and other applicable activities.
- Effectively manage direct reports, through effective participation and communication, to accomplish successful studies while promoting the development and retention of employees.
- Maintain collaborative relationships with a wide variety of functions inother departments.
Minimum Qualifications:
- Advanced degree (Ph.D.) in an appropriate discipline (e.g. Pharmacokinetics,
Pharmacology, Biochemistry, Chemistry) with 8-17 years industry experience.
- Demonstrated expertise in the design and conduct of pharmacokinetic and toxicokinetic studies and the analysis and interpretation their study data.
- Superior writing skills are a critical qualification. Experience in the preparation of global regulatory submission documents highly
desired.
- Demonstrated leadership, management and interpersonal skills and the ability to communicate results to internal and external audiences.
________________________________________________________________________
Senior Clinical Scientist
Participate in all aspects of clinical development and study management under the direction of the Director, Associate Director or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials
Duties and Responsibilities:
* Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies.
* Contribute to the preparation of Investigator's Brochures and IND annual
reports.
* Prepare study report shells. Contribute to or review drafts of study reports.
* Provide input on CRF design.
* Review edit check specifications with Data Management.
* Operationally manage one or more clinical studies.
* Participate in the development and review Statistical Analysis Plans.
* Field clinical site operational questions during conduct of the clinical trial.
* With clinical development management and other functional area input, work
with Project Management to establish and revise timelines for studies/projects.
* Closely monitor and track clinical trial progress as appropriate.
* Review lab, ECG results of patients in clinical studies looking for evidence of toxicity (or for evidence at baseline that patients with significant abnormalities are being enrolled inappropriately).
* Interact with PR & D to ensure that there are adequate clinical supplies for a given clinical trial.
* Review clinical supplies package diagram and labeling.
* Assist in planning Investigator Meetings.
* Evaluate CROs and vendors (patient recruiting services, labs, centralized ECG) for participation in programs.
* Manage CROs and vendors to ensure adherence to scope of work, budget, and timelines.
* Assist with preparations for advisory board and regulatory agency meetings.
* May contribute to scientific/clinical evaluation of potential in-licensing candidates.
* May interact with Marketing to support commercialization of products.
* Attend internal and external meetings.
* Contribute to the development of documents such as INDs, ISE, ISS.
* Assist in preparing briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results.
* Estimated travel time may be up to 10%.
Requirements:
* Qualified candidates will have a bachelor's or advanced degree in life sciences.
* Experience working in the pharmaceutical industry 3-5 years preferred and at
least 5-8 years experience in clinical research.
* Global clinical trial management experience required.
* Protocol development experience preferred.
* Medical and/or scientific knowledge in assigned therapeutic area advantageous.
* Strong written and verbal communication skills are required as well as proven ability to interact with different functional groups.
Other key qualifications include knowledge of GCP/ICH guidelines and FDA regulations, experience with clinical trial design and basic knowledge of statistics, good organizational, interpersonal and presentation skills, proficiency in computer and software skills (Word, Excel, PowerPoint).
________________________________________________________________________
Senior Statistical Programmer
Senior-level position that performs statistical programming for clinical studies and integrated summaries and in support of responses to questions from regulatory authorities. This position
requires some direct supervision.
Duties and Responsibilities:
*Perform role of primary statistical programmer on all assigned studies.
*Perform role of validation programmer on all assigned studies, assigned integrated summaries, and responses to requests from regulatory authorities.
*Create data definition tables for all SDTM and derived data sets for all assigned studies and integrated summaries.
*Create data mappings, SDTM and derived data sets, and data definition tables for all assigned partner studies.
*Review statistical analysis plans for all assigned studies and provides comments to study biostatistician.
*Represent Statistical Programming on all assigned BPSS study teams.
*Review annotated case report forms and provides comments to study database administrator.
*Review edit check specifications and provide comments to study data manager.
*Support direct supervisor and
_________________________________________________________________________
Senior/Director, Statistical Programming.
ADDITIONAL JOB RESPONSIBILITIES:
*Provide leadership with respect to Statistical Programming, BPSS, and CDMA.
*Maintains statistical programming binder for assigned studies.
*Provide training to new employees and mentor lower-level employees.
*Develops standard operating procedures for all assigned Statistical Programming processes.
Requirements:
Bachelors Degree in Statistics,Biostatistics, Epidemiology, or Computer Science, or equivalent.
Five (5) years experience performing statistical programming using SAS® in a pharmaceutical setting, or equivalent.
*Must have significant knowledge of programming of SAS®.
*Significant knowledge of drug development.
*Strong oral and written communication skills.
____________________________________________________________
Sr. Scientist/Principal Scientist - Clinical Pharmacology –New Jersey
Duties and Responsibilities:
* Independently plan and design non-clinical and clinical PK and PD studies
* Responsible for design and analyses of Phase I studies
* Contribute to the preparation of clinical study protocols and informed consents
* Work closely with Clinical Research Associates and be responsible for overseeing all aspects of study conduct including evaluation and selection of CRO, study initiation, monitoring, and close-out.
* Represent Clinical Pharmacology on Project Teams to raise and address non-clinical and clinical PK/PD, and drug metabolism related development strategies.
* Participate in the preparation of regulatory submissions including Investigator Brochures, annual IND updates, INDs, NDAs, and sNDAs.
* Perform and interpret clinical and pre-clinical pharmacokinetic/toxicokinetic
(PK/PD) analyses using compartmental and non-compartmental techniques; perform
and interpret Pharmacodynamic (PD) analyses; establish PK/PD relationships
* Author technical reports ready for regulatory submissions
* Review intra-
and inter-departmental as well as partner reports and documents
* Author manuscripts for publication in peer-reviewed journals
* Represent CPDD in corporate process Initiatives
* Contribute to in-licensing evaluations and participate in due-diligence activities
* Independently propose and defend Clinical Development Plans for new projects
* Participate in Marketing sponsored Life-Cycle Management activities of projects
* To have experience (or by appropriate training being able to develop skills) in population PK and PK/PD analysis
Requirements:
Ph.D. in Pharmacokinetics and Pharmacodynamics
3-7 years of postdoctoral and industrial experience
* PK/PD models, PK/PD software skills (WinNonlin, Kinetica, Clinical Trial Simulator and NONMEM)
* Good computer and software skills (MS Office, Sigma Plot, statistical programs).
* Good knowledge of GCP/ICH guidelines and FDA regulations and guidance
*Good understanding of the drug development process
* Excellent organizational and interpersonal skills
* Excellent verbal and writtenskills
* Excellent presentation skills
* Multidisciplinary collaborations
Sr. Principal Scientist - Fellow, Clinical Pharmacology and Drug Dynamics – New Jersey
Ph.D. in Pharmacokinetics and Pharmacodynamics with 12+ years experience in the pharmaceutical industry primarily in clinical pharmacology, and also in the preclinical pharmacokinetics and drug discovery research disciplines. This individual will have responsibility for the pharmacology, pharmacokinetics, pharmacodynamics and safety evaluation of compounds under discovery research, pre-clinical and Phase I development at company within the scope of Clinical Pharmacology and Drug Dynamics Department. This person will
lead and serve as a consultant for topics such as noon-compartmental PK, population PK-PD, MTD and QT prolongation, to the scientists in Clinical Pharmacology and Drug Dynamics Department across all therapeutic areas of interest.
Duties and Responsibilities:
-Responsible for conducting and reporting all Pharmacokinetics, Pharmacodynamics, ADME, Bioequivalence and Bioavailability studies. This includes all studies required for development and registration of drug products as well as studies in support of commercial needs with input from Marketing.
-Participates in writing package inserts. Provides input and supervision of preclinical pharmacokinetics and toxicokientics, clinical pharmacology and human pharmacokinetics and bioavailability sections of the NDA's, and SNDA's.
-Reviews in-licensing dossier, evaluates and participates in in-licensing of drug products. Conducts due diligence. Develops Clinical Pharmacology and Pharmacokinetic strategy for in-licensed compounds.
-Responsible for conducting and reporting all Pharmacokinetics, Pharmacodynamics, ADME and Bioequivalence and bioavailability studies.
-Reviews in-licensing dossier, evaluates and participates in in-licensing of
drug products. Conducts due diligence. Develops Clinical Pharmacology and
Pharmacokinetic strategy for in-licensed compounds.
-Designs study and generates clinical pharmacokinetic, bioavailability and bioequivalence reports. Directs and coordinates activities between clinical sites and Pharmacokinetics department. Analyzes data and prepares reports for IND, NDA, and ANDA submissions. Analyzes data and prepares toxicokinetic reports.
ADDITIONAL JOB RESPONSIBILITIES:
*Interact with current and potential partners.
*Represent department in project teams
*Raise critical PK/PD development issues and provide recommendations to senior management
Requirements:
Ph.D. in Pharmacokinetics and Pharmacodynamics or related field.
7+ years of relevant technical/managerial experience in Pharmaceutical Industry.
* Understanding of the drug development process
* Knowledge of GCP/ICH guidelines and FDA regulations
* PK/PD software skills (WinNonlin, Kinetica, TopFit, NONMEM, etc.)
* Good organizational and interpersonal skills
* Ability to communicate effectively verbally and in writing: good presentation skills
*Computer and software skills (Word, Excel)
_____________________________________________________________________
Modeling & Simulation Scientist - Clinical Pharmacology- New Jersey
Modeling and simulation position in the department of Clinical Pharmacology & Drug Dynamics (CPDD)
Duties and Responsibilities:
*Develop and execute appropriate pharmacokinetic (PK) and pharmacodynamic (PD) models, including population PK/PD analyses
*Provide modeling and simulation (M&S) support to development projects
*Conduct simulations to support clinical trial design at various phases of drug development
*Provide input into protocol and CRF design for collection of PK/PD data
*Create M&S datasets and/or provide PK and PD dataset specifications to statistical programmers for creation of M&S datasets
*Prepare M&S analysis plans and reports. Provide M&S input into INDs,NDAs, etc.
*Support and defend M&S analyses and interpretations at Regulatory Authorities
*Interact with outside collaborators that provide M&S expertise
*Participate in in-licensing evaluations and due diligence activities, as appropriate
*Assist in the assessment and development of new M&S software
*Mentor scientists within CPDD
Requirements:
PhD in pharmacokinetics/pharmacodynamics or related discipline, MD or PharmD
Minimum of 2 years experience in the conduct of M&S projects, preferably supporting clinical trials
*Knowledge and proficiency with the theory and application of PK/PD, compartmental, and noncompartmental analyses and fundamentals of pharmacostatistical modeling
*Hands-on experience in M&S software including NONMEM, WinNonlin, Trial simulator (TS), S-Plus, and SAS
*Knowledge of the role of PK/PD analyses in drug development and FDA/ICH requirements
for drug registration
*Excellent verbal, written, and presentation skills
*Multidisciplinary collaborations Building world class Clinical Pharmacology group for stable, successful, large company.
Seeking candidates for positions to be filled in 2010.
1) Clinical Pharmacology seeking candidates with Pop PK experience. (3 positions)
2) ExperimentalMedicine seeking candidates, M.D. and/or PhD, can consider those with all academia experience/ industry experience welcome (2 positions)
*****************************************************************************
There are many openings at local Bay Area Abbott divisions in Milpitas, Menlo Park and Alameda at . I’ve provided website where you can launch search for specific jobs of interest. Unfortunately, I don’t know anyone to whom to address your resume other than the website.
***************************************************************
Please e-mail your resume to: Human Resources, Claire.barnes@
Position Summary for Temporary Staff
Associate, Technical Operations:
As a member of the Technical Operations group, this position provides technical support across the organization for resolution of technical issues in Facilities, Engineering, Manufacturing and Quality Control. Under the direction of the group leader, the Associate will implement project tasks in support of development projects, process improvement plans, develop and write protocols and reports for process changes and investigative studies, and support deviation investigations. In addition, this position will provide technical support to licensing partners and other third parties, as required.
Primary Responsibilities
• Write and perform technical review of protocols and reports
• Write study protocols, interim status reports and final summary reports
• Develop investigation protocols and routines and assist in investigations
• Support CMC projects
• Support functional groups in the organization covering technical issues and projects
Additional Responsibilities
• Participate in cross-functional projects as technical resource
• Develop and revise operational and systems SOPs
• Perform review of validations in support of investigations
• Develop process change strategies under direction of functional head
Requirements:
• BS in Chemistry, Biochemistry, Chemical Engineering, Biology, Microbiology or a similar scientific discipline with demonstrated understanding of process or analytical science
• At least 3 to 5 years experience in a biopharmaceutical company, predominantly in either cell culture production processes (fermentation, purification, etc.) or with substantial experience with laboratory instrumentation and product testing
• Experience with process or test method troubleshooting
• Computer skills including Word, Excel, PowerPoint
• Experience with Statistical software desired
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Aliki Helman, SPHR
Human Capital Consultant/HR Director
Helping companies and people to perform at their best
aliki.helman@
(408) 807-0716 (cell)
I am looking for an Analytical Chemist with experience in animal or human nutrition/nutraceuticals for an early stage start up in Redwood City. If you have such experience or know people or places where I can find this skills, please, contact me.
The job description is below, please, review and it and email me your resume if you have relevant experience. If not, please, feel free to share it with those who you think might be a good fit.
Job description – Analytical Chemist, start up in Redwood City, CA
This is an exciting opportunity to join an early stage start up with a small, talented, hard working and dedicated team that is working on products that could change lives of many people. As everyone on the team, Analytical Chemist will “wear many hats”.
The first product is related to “animal feed” and ideally, you will bring this or similar experience (nutraceutical products, food and beverage industry, plant products...). The primary responsibility will be to do a lot of bench work improving existing products and developing new ones. We also expect the Analytical Chemist to develop processes and procedures, help establish the quality control process and quality program for manufacturing production. Entrepreneurial attitude is a must as many things will be done for the first time. This position will assist in developing new products and product certifications in response to needs from the business.
Responsibilities:
• Together with the team, work on the formulation of new products, or modification and refinement of existing products to: reduce cost, improve consistency, address regulatory compliance issues, address specific application requirements, etc.;
• Evaluate new product performance;
• Liaison with Research Teams from Universities on various projects
• Develop and maintaining procedures and processes
• Provide Data Support for Technical Literature – develop the information that is included in product data sheets and other technical marketing literature;
• Provide technical assistance to internal and external customers external by way of phone, via E-Mail, and on-site;
• Work with other departments to resolve product issues as they arise.
Your qualifications:
• M.S. Chemistry or Chemical Engineering;
• 10+ years of relevant experience in a laboratory setting, preferably working with animal feed products and/or food products, antioxidants, preservatives, natural products, immunology, bacteriology
• Understanding of chemical stability
• Experience with laboratory wet chemistry analytical and physical test methods
• Advanced analytical techniques including HPLC (High performance liquid chromatography) and Spectroscopy
• Application oriented
• Strong documentation skills, understanding of GMP, GLP
• Understands and values good processes
• Write procedures and protocols
• A plus if the individual has experience with other analytical techniques such as LC-MS, GC-MS, SFC, IC, ICP and titrimetry.
• Experience in quality management and production.
• Team player
******************************************************************
Candidates should forward their resumes
to my attention at:
jim@Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
FAX: (510) 235-4482
e-mail: jim@
MEDICAL EDITOR
My client, a San Francisco health care advertising agency is looking for an experienced editor who is ready to hit the ground running.
Experience in a healthcare advertising agency or medical journal experience is mandatory.
Primary role is to review promotional materials developed by agency team for accuracy, grammar, consistency, readability, and brand guidelines.
The agency is a full-service agency producing print, Web, video, and interactive projects; editors review projects in all media.
This position requires proficiency with Mac OS X and Microsoft Office, Adobe Acrobat, and Web-based applications.
RESPONSIBILITIES:
• Checking copy for grammar, style, and general readability (following AMA, FDA, and corporate/brand guidelines)
• Ensuring that all materials we produce are accurate and complete for both copy and graphics
• Reviewing jobs multiple times through all stages: manuscript, layout, mechanical, and printer proofs
• Assuring legal and regulatory compliance in all work (with primary account editor or copywriter)
• Checking data, graphics, captions, and references
• Enforcing style guidelines, including client preferences
• Assisting writers with implementing revisions and ordering/annotating references when needed
QUALIFICATIONS:
• At least 2 years of copyediting experience in healthcare/medical advertising or marketing
• Bachelor degree in a language-related program
• Strong knowledge of AMA Manual of Style (9 and 10)
• Proficient in Microsoft Office applications, Adobe Acrobat, and Web-based resources
• Enthusiasm for scientific information
• Familiarity with the concepts and language of statistics
• Strong organizational skills
• Professional attitude in interactions with coworkers and clients
• Great communication skills and lots of initiative!
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Michael P. Groziak, Ph.D.
Dept. of Chemistry & Biochemistry
California State University East Bay
25800 Carlos Bee Blvd.
Hayward, CA 94542-3087 USA
michael.groziak at csueastbay.edu
510.885.3407 (office)
Please forward if you know anyone with a PhD who might be interested in a bit of part-time teaching.
I found out today that our Dept. needs to hire part-time Instructors to teach a couple of Biochemistry courses this coming Spring Quarter (10 weeks, starting March 29). I immediately thought of you as a contact. So please, if you know of anybody at (or "formerly" at) Roche, or elsewhere, who might qualify (Ph.D. degree), have them apply by emailing a note and CV to my Chair, Dr. Ann McPartland (ann.mcpartland@csueastbay.edu). Here are the courses we need Instructors for:
3400 Introductory Biochemistry: A survey of biochemistry emphasizing the structure and metabolism of biomolecules such as amino acids, proteins, carbohydrates, lipids and nucleic acids. (Basically, our one-quarter "survey" course of Biochem for non-majors. A very basic, gentle treatment of the subject.)
6410 Advanced Topics in Biochemistry : (Self-explanatory, but basically, this is any topic the Instructor is skilled in and is somewhat current.)
************************************************************************ Visit to view other openings.
Andrew Youngelson
Key Recruit Inc.
You should upload your resume at and send me a copy as a Word document. Include a cover letter explaining why you would be a good fit for this position using the keywords in the job duties as a guide. Letter should include how your work in the past is relative to client needs in the present.
Sr. Director Regulatory Affairs
Date Posted: 1/25/2010 Job Id: 1701
Company: We develop and produce medical diagnostic instruments. We are also a provider of automated systems for immunohistochemistry (IHC), in-situ hybridization (ISH), and Special Stains as well as medical devices. With a large and growing worldwide install base, our advanced technologies have introduced steady and reproducible quality staining results to laboratories throughout the world.
Location: AZ
Reports To: VP Regulatory
Salary: 160-200K + depends on exp. and 20% Bonus potential
Education: Bachelors Degree in Business, Sciences, Engineering or related field. Masters preferred.
Requirements: Ten to fifteen years of progressively responsible regulatory/quality management experience in the medical device industry. Proven experience negotiating with regulatory agencies, including experience with filing of 510ks, PMAs and IDEs. International regulatory experience valuable. Must have working knowledge of medical device development process and European, US and international regulations, laws and standards covering in vitro medical devices.
Hands-on experience and scientific and technical background/training in regulatory submissions for in vitro diagnostic devices preferred. Successful track record of working in a matrixed organization and building strong partnerships with other organizations including R&D, manufacturing, clinical affairs and other senior management. Knowledge, Skills, and Abilities: - Ability to organize, negotiate, and lead team in strategic discussions with regulatory agencies. - Ability to lead discussions with executive management team on strategy and policy issues. - Ability to understand, interpret and explain complex device development details and regulations to non-experts. - Thorough knowledge of FDA and ICH regulations and requirements. - Strong leadership and team development skills.
Duties: POSITION SUMMARY: This position is responsible for the overall development, implementation and coordination of regulatory strategies and activities for company, with a focus on understanding and influencing legislative/regulatory policy issues and assessing the effectiveness of the Company Quality System.
ESSENTIAL FUNCTIONS:
1. Act as primary regulatory contact and strategist with the FDA, CMS, international regulatory agencies and other regulatory bodies.
2. Collaborate with Quality in driving compliance activities related to FDA and ISO regulations, and quality system standards.
3. Provide oversight in taking innovative ideas from proof of concept through regulatory strategy, including filing and approval. Provide regulatory oversight for Company’s product development, manufacturing and commercial operations.
4. Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
5. Monitor the US and international regulatory environments, and provide executive management with assessments of the impact of new and changing regulations on the company’s business.
6. Review and approve Company policies and procedures for the regulatory function.
7. Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation.
8. Coordinate the review and approval of product labeling and advertising. Review marketing promotional materials and provides leadership /guidance in the development of compliant sales training, advertising and detail literature.
9. Oversee the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management.
10. Develop and manage capital and operating budgets for the Regulatory Department.
_____________________________________________________________________________
Manager Regulatory Affairs
Date Posted: 1/25/2010
Job Id:
Company: My client is an internationally recognized provider of medical and dental imaging systems, healthcare information solutions; molecular imaging systems; and non-destructive products. The Clinical Affairs Department at COMPANY is a specialized clinical research and operations division of the Corporate Technology Office. Activities are dedicated in support of innovation, product development, regulatory market approval, as well as commercialization of novel and enhanced products. Our Clinical Affairs Department offers you the opportunity to work in a very innovative and exciting environment where product development cycles are measured in years no t decades, and you can participate in a variety of global studies interacting with an array of cultures. We also encourage and support continued development and career path options.
Location: Upstate New York
Reports To: Reporting to the CTO Regulatory Affairs.
Salary: to 125k plus full relocation.
Education: BS in science, engineering or relevant discipline.
Description: The Regulatory Affairs Department at Company is a division of the Corporate Technology Office. Activities are dedicated in support of product development and commercialization and post-market surveillance including adverse event reporting, international product registrations and oversight for medical device recalls. Our portfolio includes Class I, II and III devices some of which are exempt from premarket notification while others are PMA devices.
The Regulatory Affairs Manager provides post-commercialization and post-market regulatory support to company medical device products both domestically and internationally. This includes regulatory support for current product engineering, manufacturing, servicing and post-market surveillance activities. The Regulatory Affairs Manager will be required to prepare product files for submission for Class I, Class II medical devices and compliance to domestic and international governments to obtain approval to market medical devices
The Regulatory Affairs Department offers you the opportunity to work in a very innovative and exciting environment where you will be exposed to and challenged with a broad spectrum of product submissions and global regulatory requirements. For the candidate who desires to continually develop and hone their regulatory skills this is a great job!
Primary Responsibilities:
• Assist in preparation of post-marketing approval applications, such as Pre-Market Application(PMA)Supplements.
• Communicates with commercialization Regulatory Affairs manager regarding Product Hazard Risk Management, significant post-launch design changes etc.
• Prepares license amendments and annual reports to Therapeutic Directorate of Health Canada regarding Class 1 and Class 2 medical devices
• Provides documents supporting international product registrations, approvals or licenses for additional marketing approvals after product launch.
• Proficient with, communicates and verifies compliance with new regulatory requirements that impact product that is on the market
• Works closely with cross-functional teams and individuals in providing regulatory oversight for post-launch product development activities and updates post-commercialization deliverables such as the Declaration of Conformity, Technical Construction File, etc.
• Works with current product engineering/manufacturing staff to review and approve product modifications, including engineering change orders, drawings, test plans & reports, field manual or parts list updates or supplier certifications
• Participates in Corrective Action Teams post-launch.
• Reviews and approves all post-launch customer publications, labels, labeling and marketing advertising and/or promotional materials for products marketed by the company.
• Responsible for coordination, documentation and submission of Medical Device reportable events.
• Provides training on applicable medical device regulations.
• Owns Regulatory Affairs Standard Operating Procedures processes that apply. (i.e. Post Market Surveillance, EMDR Process, Electronic Radiation Report, etc.)
• Participates in product quality investigations and Regulatory Agency inspections including internal and external audits
• Functions as a product line expert within Regulatory Affairs.
• Provides guidance and support to QA and QE for post market adherence to GMPs, QSRs, and GCPs.
Requirements:
5+ years of regulatory affairs experience; medical device or related industry experience preferred. This experience should have included responsibility for at least one program area incorporating the exercise of independent judgment in the performance of assigned duties.
Knowledge of applicable FDA device regulations (e.g. GMPs, Device classification, pre-market submission and registration requirements, labeling and advertising requirements and restrictions, MDR reporting, and recall procedures).
Knowledge of applicable international medical device regulations and standards (e.g. Medical Devices Directive, Canadian Medical Devices Regulations, MEDDEV guidance, ISO 13485, ISO 14971, etc.).
Excellent written, oral and interpersonal skills. Exhibits a high degree of integrity, initiative and motivation. RAC Certification highly desired. Experience interacting with Health Authorities. Global experience preferred.
_____________________________________________________________________________
CLINICAL AFFAIRS MANAGER- Upstate NY
Posted: 1/15/2010 Job ID: 1700
My client is an internationally recognized provider of medical and dental imaging systems, healthcare information solutions; molecular imaging systems; and non-destructive products. The Clinical Affairs Department at COMPANY is a specialized clinical research and operations division of the Corporate Technology Office. Activities are dedicated in support of innovation, product development, regulatory market approval, as well as commercialization of novel and enhanced products. Our Clinical Affairs Department offers you the opportunity to work in a very innovative and exciting environment where product development cycles are measured in years not decades, and you can participate in a variety of global studies interacting with an array of cultures. We also encourage and support continued development and career path options.
Reports To: Director of Clinical Affairs
Salary: Salary to 125k. Relocation provided.
Requirements:
BA/BS (MA/MS preferred) degree in applied sciences discipline.
Knowledge and working experience under ICH-GCP guidelines, FDA and foreign regulatory requirements, and project management of clinical studies.
Experience in all aspects of developing and executing clinical studies. Must have experience developing clinical protocols!
Experience in a medical device or pharmaceutical experience highly preferred.
Background in statistics, multivariate statistics and/or design of experiments.
Experience and ability to work with office automation programs and corporate databases
Excellent communication skills both verbal and written with the ability to communicate to technical and non-technical audiences.
Willing to travel up to 25%, domestic and internationally.
Ability to work in a global business environment.
Strong problem solving and analysis skills; ability to work well in a fast paced environment and deliver with quality.
Duties:
Position Overview:
The Clinical Affairs Manager provides clinical research program management for specific studies as directed by the Director. Responsibilities include designing, managing, executing, and reporting pilot studies, trade trials and/or clinical trials. In close collaboration with Regulatory and Product Development teams, ensures all clinical activities are conducted in compliance with Clinical Affairs standards, laws and regulations concerning the conduct of human subject testing for all regions in which devices are marketed.
Responsible for all aspects of planning and conducting a clinical study: determine scope, duration, and cost of site initiation, monitoring, closeout, and data collection and analysis.
Interacts with FDA and other regulatory bodies in support of global submissions to negotiate product claims establishing requirements for clinical studies, and to answer questions with supporting research publications and clinical data.
Authors clinical protocols and supporting documents (informed consent, investigators and IRB approvals, case record forms, clinical summary reports, technical/research publications, etc.) for human subject studies.
Negotiates contracts and manages partnerships with study sites, clinical investigators, and contract research organizations (CRO).
Follows policies and procedures as well as drives improvements in the conduct of clinical studies, ensuring patient safety and strengthening outcome.
Provides clinical support and expertise for internal departments: marketing, regulatory, innovation, development, and sales.
Performs other job-related duties as assigned. *****************************************************************************
Andrew Brogan
Director of Business Development
F-O-R-T-U-N-E Consultants, New York City
145 West 45th Street, 8th Floor
New York, NY 10036
P - 212-302-1141 X233
C - 914-589-0731
F - 212-302-2422
Position: Marketing Manager-Northern California
DESCRIPTION: Downstream Marketing
Roles and Responsibilities: This position has responsibility and authority for:
• Lead and implement marketing plans and key marketing programs to drive procedure adoption amongst hospitals.
• Develop and implement presence at key healthcare conferences, including robotics symposia, hospital executive meetings, tradeshows, and promotional events.
• Partner with Training Department to identify and support the development of new training programs to meet our procedure adoption goals and sales goals. Partner with key hospital administrators to develop and implement leading programs and service-lines in hospitals.
• Work closely with key surgeons and product development to define marketing and product requirements for new products needed to further enable key procedures and drive procedure adoption across multiple specialties.
• Develop strategy, content, and support for surgeon/hospital marketing programs designed to drive patients, practices and hospitals.
• Work closely with e-marketing and marketing communication groups to optimize hospital administration content and material
• Collaborate with surgeons & hospital administrators in the development of administrative whitepapers to help promote strategic/financial competitive advantage the service line offers.
• Lead field communications to launch new products and promote key marketing programs throughout the organization.
• Train new sales hires on marketing goals, surgeon targeting, procedure positioning, sales support, executive presentation skills, and key marketing strategies to drive adoption
• Develop and update sales support tools for key strategic marketing programs and messages.
• Develop positioning, messaging, pricing and value proposition for new products
• Analyze ROI on new marketing campaign expenditures and programs
• Work closely with field sales management team to implement new strategies, garnish opinions and feedback, and foster collaborative relationships
Attend and actively participate in sales and marketing meetings domestically and internationally.
Requirements:
Competency Requirements: (Competency is based on: education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must:
• Product marketing experience in a therapeutic medical device company. Surgical and/or OR experience desired.
• Bachelor's degree in life science or business discipline. MBA desired.
• Proven ability to effectively position and message product/procedure and develop strong sales support to drive product/procedure adoption. Demonstrated success in building clinical education and marketing programs to drive product/procedure growth.
• Demonstrated ability to work creatively amidst competing priorities to deliver high-impact marketing programs on-time and within budget to support overall marketing strategy and business objectives.
• Superior verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents.
• Self-starter with ability to take leadership in unstructured environment.
• Able to prioritize and smoothly manage multiple tasks.
• Must be well versed in MS Office Suite.
• Understands and is comfortable with economic / finance fundamentals and analysis
• Ability to travel 35%. Some international travel will be required.
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If interested contact Rob Natowitz at
rnato@ phone 404-474-302
Global Marketing Manager (based in the Northeastern US)
Dynamic start-up opportunity. Responsible for developing and executing
global marketing strategies to support the development and increase of
product sales and profits around the world. Interact closely with direct
sales, distributors, product development, clinical, regulatory and finance
personnel to ensure that all product launch activities are properly
coordinated and all objectives are successfully met. Develop distribution
network and assist sales force in implementing marketing product programs.
Develop product comparison and competitive strategies. Ensure coordination
of clinician training, clinical and regulatory affairs activities, product
education and reimbursement. Act as company liaison with governmental
agencies, medical associations, and medical institutions to ensure
regulatory compliance. Minimum of 10 years experience in the medical
device/pharma industry with a minimum of 5 years of marketing experience in
medical device field required. Experience in Interventional Radiology
products with an emphasis on Oncology is strongly preferred. Foreign
language fluency and sales experience are a plus. This is a road warrior
position with extensive international travel.
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Jobs That Crossed My Desk Through Jan. 24, 2010
*************************************************************
Contact:
Marjorie E. Saraga
Senior Staffing Specialist
The Clinical Resource Network
260 Madison Avenue
New York, NY 10016
Email: msaraga@
Medical Writers, Contract
Southern CA
Southern CA-based CRO is in need of two part-time contract Medical Writers as follows:
1. Writer with ISS/ISE experience who is also familiar with pain management studies. The ISS/ISE project is 6-8 weeks, beginning in March 2010, and would average 50% time (probably more the first few weeks and than again at the end with less time required during review/revision cycles).
2. Medical writer who has substantial experience writing CSRs (particularly phase 1 and 2; in multiple therapeutic areas, the more the better. The CSR project is ongoing on an as needed basis. Each CSR project takes ~4-5 weeks at 40-50% time. There will be times they are needed and times they are not.
*Candidates will be home-based, but on occasion, will need to go in for meetings etc.
Contracts would be written for a year and they would work when needed and available.
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Contact:
Resumes should be sent to anita@pse-. Questions should be directed to Anita at 215-456-9066.
Clinical Publishing Lead
Wilmington, DE
Major Responsibilities:
• Delivers the US-specific publication plans
• Ensures that statements and conclusions in publications are supported by appropriate data
• Provides leadership of cross-functional US Product Publications Delivery Team charged with delivering the US Publication strategy and plan
• Consults and liaises with external authors on matters related to publications activities
• Identifies and manages publications agencies through the effective use of project management skills to ensure the delivery of quality documents
• Edits, as appropriate, publications deliverables (eg, manuscripts, abstracts, posters)
• Participates in the negotiation and management of US publication budgets with US product team
• Works closely with the Global Publication Manager on all aspects of publication planning and delivery, eg, directs and manages the US review of non-US components of the global publication plan
• Contributes US perspective to the definition of the global product publication strategy and plan (in conjunction with the US and global publications teams for a product)
• Interprets and monitors current and emerging clinical communication issues and guidelines and advises the US Product Team on these issues
Minimum Requirements:
• Baccalaureate degree in biomedical discipline or equivalent
• Knowledge of the drug development process and human patho-physiology and diseases
• Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly
• In depth knowledge of, and experience (5 to 7 yrs) in, the preparation of a wide range of publication types (eg, peer-reviewed journals, scientific meetings and congresses)
• Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management
• Knowledge of external publication guidelines and standards
• Ability to travel nationally and internationally
• Ability to work effectively in a cross-cultural business environment
• Influencing and negotiating skills
Preferred Background:
• Advanced biomedical degree
• In depth experience (7 to 10 yrs) in publication management
• Demonstrated budget and resource management skills
• Previous experience in TA areas of AstraZeneca product
• Awareness of pharmaceutical business practices
• Knowledge of competitors and competitor products
• Editor in Life Sciences (ELS) certification
Hours: Mon - Fri; 8:30am - 4:45pm
Contract Term: 01/04/10 - 01/04/11 (with potential for extensions)
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Contact:
Paula Rutledge
Paula @
407-898-4440 X 106
VP of Quality and Regulatory - East Coast - $175,000 base++
Summary: 15 years+ experience with a strong Regulatory background in PMA and IDE processes for Class III IMDs - preferably in Sports Med, Ortho, Neuro, or Biologics. Start up company headed by a 3 time homerun hitter who has sold prior companies for well over $1B.
_____________________________________________________________________________Director of Sales - Orthopedics - South - $175,000 base; $275-$300,000 at plan ++
Summary: 20 years experience with experience leading sale force integration due to acquisitions. Orthopedic experience preferred not required (but must have managed a direct surgical sales force). Strong strategic orientation - will need to have a commanding and credible style to retain current top performers and also be adept at the long-term alignment, compensation, and growth/development. 10 direct reports - RMs, some marketing.
_____________________________________________________________________________
Product Manager - Spine - Southwest - $125,000 with rapid advancement
Incumbent is being promoted during critical pre-launch - so this is a urgent, immediate hire - and candidate must have spine marketing experience and be "plug and play" relative to anatomy knowledge, market and competitive activity. This is our third similar position in 90 days. Please contact Joy Bridges about this one. 407-898-4440 X 104
We have other searches (Sales, Marketing, Product Management, Engineering, R&D) in cardiovascular, robotics, ophthalmic, MIS, biologics and as always, orthopedics, spine, and imaging.
Two are international.
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Steven Chamow, Ph.D.
S. & J. Chamow, Inc.
Biopharmaceutical Consulting
CMC Outsourcing-Process Optimization-Project Integration
747 Laurelwood Drive
San Mateo, CA 94403
650 345 1878 tel/fax
smchamow@
I am working with a US-Chinese joint venture group that is building capability to do mammalian cell biologics production in China. The group needs process and manufacturing expertise to lead efforts on the ground. This is a consulting position working with me in cell culture process development, part-time for approximately an 18-mo term. Please see attached description. Proficiency in Chinese is desirable, but not mandatory
Consultant is required to:
• Facilitate process development and optimization for mammalian cell culture. Design and qualify bioreactor and process skid for development and manufacturing operations; perform medium optimization for high density CHO cell culture process. To support process validation, write protocols, supervise experiments, and write reports.
Requirements:
• Expert in mammalian cell culture for production of protein therapeutics
• Experience with batch, fed-batch process scale-up including transfer from laboratory to 100 L manufacturing scale
• Familiar with regulatory, quality, validation, compliance to support manufacturing for FDA approval
• Must be willing to work on location in China as needed (up to one week per month)
• Project will require 18 mo commitment, part-time
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Contact:
Email your resume to MedFocus, LLC, at afink@.
Medical Writer- Winston-Salem, NC
• Develop and update editorial style standards, provides guidance to project teams regarding regulatory submissions, and develops and updates general writing guidelines.
• Document, review, update, and maintain Standard Operating Procedures (SOPs) for all medical writing activities in accordance to good Clinical Practices and Federal Regulatory requirements.
• Participate, as needed, in the creation of SOP templates for all functional areas and with QA staff.
• Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other internal departments, as necessary.
• Other duties, as assigned.
Qualifications:
• BS + 5 years experience with pharmaceutical industry scientific/medical/regulatory writing/editing, and manuscript preparation for technical documentation
• Scientific or medical background, as applicable
• Working knowledge of applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and assure compliance with SOPs
• Extensive experience with writing phases 1 through 3 CSRs, INDs, NDAs, narratives, investigator brochures, ISE/ISS, and other clinical documentation.
• Experience in data handling and analysis
• Good written and verbal communication skills
• Ability to write fluent and grammatically correct English
• Good word processing skills and good at working with templates
• Good organizational and time management skills
• Pays attention to detail
• Able to work to tight timelines while maintaining accuracy
• Team player
• Familiarity with Quality Assurance and Quality Control procedures
• Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions-Proficient with Word and electronic templates
• Able to work proactively with minimal supervision
• Able to manage several studies and enjoy analyzing the cause of problems, finding the right approach and directing the implementation of solutions
• Must be able to work 100% in-house. No telecommute. No work from home.
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Contact:
Fredy Chu 朱建超
HK (852) 9475-3313
PRC (86) 134-1050-7377
USA (1) 650-269-8759
caredust@
I am looking for candidates to fill two positions for a start-up biotechnology facility in China. These are regular full time employment positions located in China. Proficiency in Chinese is desirable, but not mandatory. Competitive compensation and benefits. Appreciate a referral if you know of anyone who might have the right background.
1. Biotechnology purification engineer. Experienced in biologics purification process development, with emphasis on monoclonal antibody, protein and vaccine.
2. Quality Assurance engineer. Experienced in GMP operations and documentation. Initial duties will focus on facility start-up, including facility/utility design, installation and validation. Will take on QA responsibilities when plant is complete. Background in biotechnology or pharmaceutical process and analytical development helpful.
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Contact:
D. Tony Zhang, Ph.D.
President and CEO
Formurex, Inc.
2470 Wilcox Rd.
Stockton, CA 95215
Phone: (510) 206-4667 (Cell)
Fax: (209) 774-1888
Formurex () is a pharmaceutical CRO based in Stockton, CA. We are looking for professional BD/Sales personnel, full time or part time. If you know someone who may be interested, please let me know. Thank you for your time.
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Contact:
Email your resume to MedFocus, LLC, at afink@.
Senior Medical Writer
Montville, NJ
A Major Pharmaceutical Company is looking for a Sr. Scientific Medical Writer in Montville, New Jersey!
The Senior Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
• Participating in the development of the strategy of the submission and the label and the carrying through of those key messages into other regulatory documents
• Assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Requirements:
• Bachelor's degree or equivalent, with a minimum of 6 years in Medical Writing.
• Master's degree, PhD, or equivalent with a minimum of 5 years previous industry experience and three years of medical writing experience.
• Demonstrated working knowledge of scientific principles.
• Excellent written and oral communication skills in English.
• Familiarity with all phases of medical research and ability to learn new medical concepts quickly.
• Familiarity with statistics and experimental design.
• Ability to summarize complex data and identify relationships.
********************************************************************
Contact:
Email your resume to MedFocus, LLC, at afink@.
Medical Writer
Montville, NJ
A Major Pharmaceutical Company is looking for a Scientific Medical Writer in Montville, New Jersey!
The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
Assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Requirements:
• Bachelor's degree or equivalent, with At least 6 years experience in a scientific discipline and a minimum of 4 years in Medical Writing.
• Master's degree, PhD, or equivalent with a minimum of 2 years previous industry experience.
• Demonstrated working knowledge of scientific principles.
• Excellent written and oral communication skills in English.
• Familiarity with all phases of medical research and ability to quickly learn new medical concepts.
• Familiarity with statistics and experimental design.
***************************************************************************************************
Contact:
Email your resume to MedFocus, LLC, at afink@.
Medical Writing Specialist
Montville, NJ
The Medical Writing Specialist is responsible for the tracking, quality control and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents.
Responsibilities:
• Working together with key interface partners (eg, Study Management, Statistics and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review, and ensure timely completion of high quality regulatory documents.
• Checking that study file components (eg, Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements.
• Acting as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guides to reflect new agreements and changes due to SOPs and regulatory guidelines.
• Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
• Performing real-time edits to clinical documents during comment review and resolution meetings.
• Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation, and electronic publishing.
• Managing the review and approval of documents in the document management system using standard procedures.
Requirements:
• Bachelor's or Associate's degree with strong electronic documentation and word-processing skills
• Excellence in written and oral communication skills in English
• Excellent interpersonal skills
• Familiarity with clinical research, statistics, and regulatory submission requirements preferred
• Must be able to work 100% in-house. No telecommute. No work from home.
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Please reference Job # 1 if submitting a resume or interested in the opportunity to: mtakahashi@.
Director, Product Marketing - Liquid Handling Automation - Northern California
We are exclusively engaged with the leading developer of cutting-edge liquid handling systems to the life-sciences, research and biopharmaceutical markets. Their green technology provides significantly better analytical results while saving money. They are looking for a Director, Product Marketing based in Northern California.
The company:
- World leader in liquid handling technology for pharmaceutical and life science applications
- Their technology provides dramatically better answers by eliminating pipette tips and the adsorption of compounds during transfer, while saving hundreds of thousands of dollars in decreased consumables
- The company is cash positive and is growing 35% annually.
- 48 patents issued in US, Europe and Japan.
- Their technologies have broad applications including the fields of compound management, genomics, proteomics, particle manufacturing, encapsulation, imaging mass spectrometry, and live-cell transfer.
We are ideally looking for:
6+ years of life science/product management experience
In-depth knowledge of liquid handling, automation and robotic laboratory equipment
An outstanding track record of introducing and managing complex product lines
Strong leadership skills
Excellent interpersonal, written, verbal, and presentation skills
Highly knowledgeable in life science applications with an emphasis on compound management and screening for drug discovery, Genomics, and Proteomics
A BS level life Science degree, MBA preferable
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If it's a match, please send your Word 2003-formatted resume to Doug Gabrielson, Eclectic Search, at doug@. We're working directly with the hiring manager, and you will hear back from us. Competitive compensation package. Relocation is possible.
SF Bay Area Jobs - R&D Engr & Mgr, Medical Device
Established San Francisco Bay Area Medical Device company is expanding its R&D team. Become a key player on the development team that defines and brings complex, cutting-edge electro-mechanical systems, incorporating robotics and flexible catheters, to life. (summary below).
R&D Manager/Principal Engineer: Very strong technical credentials in the industry, with proven leadership skills of engineering teams that incorporate diverse technical disciplines, including precision robotic control systems. BS required, MS Mechanical Engineering preferred. Excellent communicator, collaborator, project manager, who is a veteran in leading multiple, complex projects through all phases of development, optimization, and transfer to manufacturing. Well versed in related ISO, GMP, FDA.
Sr. Mechanical Engineer: Be a strong contributor on the diverse product development team at both the product definition/architect level, and the hands-on detail-level, involving the integration of complex electro-mechanical systems. Proven experience in efficiently gathering data and building functional prototypes. Good knowledge of servo-mechanisms, system/sub-system test, analysis, performance optimization. Excellent collaboration skills with diverse development teams. BSME (Master's and medical device experience strongly preferred). 5+ years' SolidWorks, strong analytical skills, FEA modeling, e/m control systems, dynamic modeling or servo-tuning desired. Design/test/BOM/documentation/assembly & test processes/FDA regs.
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If you are interested and qualified, contact:
Sandor Schoichet
Director
Meridian Management Consultants
sschoichet@
415.828.1302
MARKETING COMMUNICATIONS MANAGER JOB DESCRIPTION --Berkeley
Sensys Networks has a great opportunity for an experienced Marketing Communication Manager to implement a marketing and communications plan for a fast growing technology product company. Hiring manager is looking for a superstar copywriter with loads of product marketing experience, as senior a person as possible who wants to be an individual contributor. Writing, graphic design, public relations and market communications planning are all key skills. Of course, since Sensys Networks is a 50-person venture-backed start-up, entrepreneurial experience is a plus.
About Sensys Networks: Our Company designs, manufactures, and markets a family of wireless sensor systems for vehicle detection and data collection for the transportation industry. Sensys Networks is the leader in ultra-low power wireless sensor networking for traffic applications. Our products are built on patented power management and wireless networking software, enabling high performance vehicle detection products in the growing international market for Intelligent Transportation Systems.
We are a venture funded technology start-up, with over 140 clients and a track record of profitable operations and rapid growth. Our team of experienced entrepreneurs shares a common vision for the long term benefit of our products. Open communication is encouraged in this fast paced, professional and trusting environment. Sensys Networks’ believes in hiring, developing and rewarding top talent who bring passion, intelligence and dedication to the company.
Visit us on the web at: .
Primary Responsibilities:
• Write company and product messaging to communicate company vision and product differentiation.
• Design, write and maintain collateral materials to support Product Management and Sales. This includes data sheets, brochures, flyers, success stories, web content, video scripts and application notes.
• Design, write and communicate effective public relations materials to include news releases, email campaigns, advertising, and trade show or industry association support materials.
• Develop and execute a marketing communications plan that addresses Sensys’ audience including customers, distributors, contractors and corporate partners.
Sensys Networks
• Develop and oversee the national and regional event plan, including conferences, seminars, industry association meetings and trade shows.
• Represent Sensys at industry meetings and give public presentations.
• Lead content development and manage the on-going maintenance of company website. Help develop high-impact web strategies based on the company’s needs and sales objectives.
• Participate in product management, marketing and sales events.
Qualifications:
• Five or more years of successful experience in marketing communications in a technology product company.
• Strong verbal and written communication skills.
• Strong graphical design skills.
• Experience managing people, projects, consultants, contractors and vendors.
• Experience with website maintenance and re-design a plus.
• Ability to manage and complete multiple activities concurrently.
• An independent self-starter with experience balancing the needs of product management, market research and sales.
• Adaptable and flexible to changing market and customer needs.
• Passionate, tireless entrepreneurial spirit.
• BS in marketing, communications or a related field required.
***************************************************************
Contact:
If you're interested in the position, please email your resume to Nishit Modi at nmodi@.
Permanent Medical Writer Needed for San Francsico Bay Area Company
Impax Pharmaceuticals, San Francisco Bay Area, a division of Impax Laboratories, Inc., is seeking a permanent medical writer.
Note: the candidate must be local to the SF Bay Area and able to work on site in the East Bay.
The position is a permanent one, with the title going as high as Manager of Medical Writing for the right candidate. Some supervisory responsibility may be involved, and the writer will be doing regulatory writing as well. Here's a description of the position:
Responsibilities:
• Will be responsible for writing and editing CMC, nonclinical, clinical and regulatory documents (including protocols, reports, investigator brochures, SOPs, submission dossiers and CTD) in accordance with regulatory requirements and company standards.
• Participates in the development of scientific abstracts and manuscripts.
• Develop document templates, process and timelines for documents production and review as appropriate
• Serves as a resource for writing standards and may be called upon to provide training on writing style
• Collaborates with functional areas and external partners to ensure the production and review of documents within agreed upon timelines.
• May manage contract medical writers.
Requirements:
• Minimum 5 years of previous writing experience in a pharmaceutical environment
• Bachelor's degree in a scientific discipline required; Advanced degree (MS or PhD) would be a plus
• Strong verbal and written communication, interpersonal, and time management skills
• Ability to work well in a matrix environment
• Demonstrated ability to write clearly and concisely, including ability to convey key messages
• Strong computer skills including versatility with Word, Adobe Acrobat, and graphic packages. Experience with electronic submissions would be an asset.
• Knowledge of good document management practices and ability to interpret and effectively communicate scientific information
• Attention to detail and ability to meet deadlines
• Familiarity with FDA and ICH guidelines and the drug development and approval process
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Other Information for Those in Transition
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UCSC Ext. Bioscience Product Marketing, Thursdays, Feb. 11 – March 25, 2010
Course Description
This product marketing and selling-focused course gives participants an in-depth look at product planning and research, marketing planning, and promotional execution practices in the bioscience industry. Topics include market research methodologies, information sources and applications relevant to product planning; the development of marketing strategy, product positioning and differentiated claims; and the creation of tactical marketing programs and activities to maximize revenue potential. Course activities include the creation of a preliminary marketing plan.
The course is well suited for all levels of professionals in bioscience marketing research, product management, product sales, advertising, public relations, business development and licensing, as well as other related functions, such as regulatory, clinical and legal.
Lead Instructor:
Audrey Erbes, Ph.D., is a life science business development and marketing consultant with more than 25 years of managerial experience in marketing and business development in the biotech and pharmaceutical industry. She was Executive Vice President and cofounder of Kowa Research Institute and held management positions at Syntex Corp. in market research, product management, strategic marketing and planning, and business development in the U.S. and abroad.
Dates and Times: Thu 6:00PM to 9:30PM
Feb 11, 2010 to Mar 11, 2010, Thu 6:00PM to 9:30PM,Mar 25, 2010
Number of Sessions: 6
Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara
Tuition: $700 (Early enrollment - $630 through Jan. 28)
See details at ucsc-extension.edu/BPM
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Biotech Bay Career Fair, Tuesday Afternoon, March 9, 2010
Event: Biotech Bay Career Fair
Location: South San Francisco Conference Center
Date and Time: Tuesday, March 9, 2010, 2pm to 7pm
Register now at:
Event Description
Looking for a new job? Networking with industry peers in an ever-changing work environment?
Sectors include: Biotech * Pharmaceutical * Medical Device & Diagnostics
Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay area.
Who should attend?
Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. Just register by clicking the button below.
(Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)
What types of positions are available?
Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.
What companies will be there?
Take the time to research what each company is recruiting for to see if you are a match. Most companies will be from the Bay area, but some will travel from other regions to attract top talent! If you can’t make it on event day, you can still pre-register online to allow exhibiting companies to view your resume and contact you outside of the career fair.
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Paula Rutledge, President of Legacy MEDSearch, has provided the following
Job Search and Interview Preparation Resources to share with you:
▪ Interview Preparation Resources: Interview Prep Guide
▪ Medical Device Research Forum Medical Device Guru
▪ LinkedIn Medical Device Group LinkedIn Medical Device Group
▪ Interviewing Videos on YouTube Medical Career Magazine
Although the above was developed with medtech professionals in mind, the processes outlined are also useful for other industry professionals.
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Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.”
The link; .
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Job Sites
The most known site for career and job listings is which focuses on biotech and pharma.
A newer website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled at
There’s another site which is focused on life science recruitment and placement; note featured company listings each week—
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
I’ve just received information on another new site with sole focus on medical devices and most in the Bay Area is I’m told they had 97 placements last year. Check this one out and let me know if you have good results.
You can look up pharmaceutical jobs in your area by zip code at . They include all functions in pharmaceutical companies.
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Other Helps
I received Biotech Ink Insider from Susan Caldwell, a local medical writer. She always has great insights as well as jobs at times to share. I’ve pasted in some videos mentioned by Susan that might be of interest for your job search:
Writing a Resume: When seeking a job, the resume is of considerable importance--it's your calling card and door opener. Here's a video that helps you create the right resume and minimizing the stress while you do it. Includes ten rules for how to approach your resume, interview, and job search. Very good basic advice.
Writing Your Resume Cover Letter: Same instructor as for Writing a Resume (above). Gives good basic advice on how to craft your cover letter and get the job interview you seek.
The Art of Medical Writing: Short video on the Masters in Medical Writing program at the University of Philadelphia, the only such training program in the world.
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Susan Caldwell wrote an article regarding writing a resume as well.
“10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell
If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers.
As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:
1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database.
Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance:
Introduction or Career Goal
Summary
Work History or Professional Accomplishments (if candidate has work history)
Academic Background
Skills
Honors and Awards
Publications
There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections.
When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization.
2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.
3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume.
4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies.
5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.
6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice.
The remaining points in this article address issues within your resume's sections:
7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.
8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.)
A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.
As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history.
9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.
10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers.
Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.
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About the Author
Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.
You can email Susan at caldwell@, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved.
*****************************************************************************Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing.
As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
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Salary Surveys
▪ See free downloadable annual Salary Survey from Contract Pharma at
▪ Salary surveys are regularly published Medical, Marketing Media each year in September
▪ See 2009 Medtech salary survey at Source:
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Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, , published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at .
This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search () and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.
The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon.
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These job postings are listed on my blog accessed at along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@ if they wish to receive these mailings directly.
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