Jobs That Crossed My Desk Through Sept
Jobs That Crossed My Desk Through Sept. 27, 2009
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.
Product Manager, Arthroscopy
Part-time Consulting Position
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My employer, SuperGen, is re-opening a Scientist I, Formulation position that had been previously posted in February 2009. My apologies to the person who had emailed me a few days ago about this opportunity and I had incorrectly replied that the position was closed. I have since spoken to HR and they have confirmed it has been re-opened.
This position is already posted on a few external recruitment sites, but is not yet on our website (will be there tomorrow).
Job description appears below. Anyone who is interested can either apply through our website tomorrow, or send your resume to me at schau@.
Susanna Chau
Investor Relations Manager
SuperGen, Inc.
Scientist I, Formulation Development
"Work for a company that is making a difference in the fight against cancer". SuperGen, Inc. () brings together high tech and biotech to search for new, more effective drugs for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. The candidate will be working in the Laboratory located in Pleasanton, California.
Develop, optimize and characterize formulation of small molecules for oral and parenteral administration in pre-clinical and clinical studies. Demonstration of oral dosage form development is preferred. This is a bench level position that involves extensive formulation development and reasonable analytical method development skills to the extent of guiding formulation development. Hands-on experience in these areas is required.
This is a bench level position that involves extensive formulation development and reasonable analytical method development skills to the extent of guiding formulation development.
• Perform preliminary analytical method development to support pre-formulation and formulation studies
• Conduct pre-formulation activities, such as (pH-dependent) solubility, stability, and excipient compatibility testing of new chemical entities (NCEs). Determine physicochemical properties of NCEs
• Develop oral and parenteral formulations of adequate stability for research, pharmacology, toxicology and early clinical studies; Optimize formulations for Phase 1-3 stage clinical trials
• Design and conduct stability studies at various stages of formulation development
• Characterize prototype formulations and support transfer of corresponding analytical methods to the analytical group
• Evaluate the potential for enhancing oral bioavailability of lead drug candidates through conventional or state of the art formulation technologies. Propose and design novel delivery systems as appropriate for the projects
• Work closely with analytical and manufacturing groups. Actively support testing of new drug formulations at various stages of development, meeting project timelines and goals
• Represent the formulation group in various inter-disciplinary settings and write relevant CMC sections for regulatory filings
• Present results at meetings and in technical reports/publications
Education:
Ph.D. or M.S. in pharmaceutical sciences or equivalent. Ph.D. with 0-2 years experience or M.S. with 5-8 years experience in a pharmaceutical industry.
Benefits:
We provide a comprehensive benefits package to include medical, vision, dental, short and long term disability, group term life, 401(k) and an Employee Assistance Program.
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Six jobs at local Intuitive Surgical in Sunnyvale from
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|Manufacturing Engineer, Electrical |
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|Sr. Manager, Instrument Development Engineering |
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|Sales Training Manager |
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|Training · Creation of agenda, curricula and training materials for all Clinical and Sales Training at I... |
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|Assistant Video Editor |
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|Position Description · The Assistant Video Editor will work under the direction of the Video Productio... |
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|Document Control Specialist |
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Tammy Harris of Harris Recruiting LLC (205) 421-1772 or harrisrecruiting@ if interested in this job.
Summary
The International Regulatory Affairs Specialist prepares, reviews, compiles, and submits international regulatory filings. He/She may also participate in the preparation of international product registrations with in-country managers. He/She monitors and tracks information of individual country requirement changes and maintains departmental databases and filing systems for regulatory submissions and related documents.
The International Regulatory Affairs Specialist works independently on most assignments, utilizing information from multiple sources to solve moderately complex problems. He/She exercises independent judgment and decision making on matters within standard company policies and regulatory requirements.
Responsibilities
• Receives timely international product and or marketing approval for the International Department.
• Coordinates and prepares technical files/design dossiers for International Country Registrations (excluding European Union Medical Devices Directive CE mark requirements).
• In addition to the required technical documentation, he/she will also supply samples, packaging, manufacturing site quality system certificates, and certificate of free sale, etc.
• Maintains and updates the International Country Registration Database.
• Maintains Regulatory Library with copies of all country registration files. Amends and updates as necessary.
• Using standard programs and systems, ensures accuracy and completeness of regulatory submissions, filings and tracking methods.
• Reviews initial product labeling and marketing materials to ensure compliance with the specific international country labeling requirements.
• Keeps ahead of international regulatory requirements and changes within the regulatory registration process. Advises management on future international in-country regulations.
• May have direct interaction with government and regulatory agencies on specific issues.
• Reviews and advises on international product registration requirements, making recommendations to management regarding regulatory process and strategies.
• Identifies issues or areas of concern and resolves routine problems.
Education/Experience
• Bachelor’s Degree (B.A.) from four-year college or university and
• A minimum of five years experience in the medical devices industry dealing with international country registrations
E/O/E M/F/DV_._,_.___
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Email resumes to: charlesj@
Charles Jo
Recruiter/Sourcer
408.668.4226 charlesj@
Bio
Jobs
Quality Manager/Director for SF Bay Area medical device co [Req#09CJ14]
And list of many other jobs at
*********************************************************************************************
Lee Gellins
Fortune Personnel of Hilton Head
843-842-7221
Lee@
All of these listings require current/recent Medical device experience. Engineering degrees required (BS minimum)
California
Sr. product design engineer
Must have silicone molding experience (preferably in the Medical device industry)
Proficient with Solidworks
Project management skills
Experience with design controls, risk analysis and ability to verify product requirements
Designs test fixtures
Ability to work with various levels of candidates, vendors, surgeon and ability to articulate ideas
***no relocation offered*****
__________________________________________________________________________
Sr. Process Engineer (can be located in CA or Boston area)
50-75% travel required
This person will work with several facilities and departments
Hands on experience processing silicone molding
Lean/six sigma background
Technical expert with excellent problem solving skills
***no relocation offered***
California (con’t)
__________________________________________________________________________
Manufacturing Engineering Manager
At least 8 years of hands on experience with liquid silicone molding experience in the Medical device industry.
Involved with Product design, development and set up of equipment and processes for molding and extrusion of medical device products. This person should be very hands on- and a mentor to junior engineers. Strong product engineering and tooling experience . Lean/six sigma focused.
*** no relocation offered***
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South
Principal R&D Engineer
Pro-E expertise. Hands on CAD and project management experience.
Some supervisory experience as they will have 1-2 reports.
Will work with motors and moving parts.
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Southeast
Principal R&D engineer
Electromechanical background. Production background.
Pro – E expertise.
FEA experience
10-15 yrs experience
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Manufacturing Engineering Manager
Very metrics driven company. This manager will be involved in the
Day to day operations of the facility both on the sustaining and new product development side.
Lean/six sigma focused. Must already be a manager as they will have 5-7 reports.
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Mid Atlantic
Process Development engineer- Catheters
Plastics, extrusion, mechanical engineer, polymers
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Mid level design engineer
Designing prototypes
Testing disposable plastics
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Sr. Process Improvement Engineer
Manufacturing support
Validations
Lean Mfg/ Six Sigma certifications
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Sr. Engineer
Product and process development
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Sr. Product development engineer
Reports to the Director
Has one person reporting to them
Vascular, catheters, stents
High profile role
_______________________________________________________________________________
Northeast
Mid level R&D engineer (Boston area)
Previous work with Catheters
Solidworks experience
** no relocation assistance offered**
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Sr. Supplier Engineer (Boston area)
Work with vendors to identify cost reduction opportunities.
Know the medical device manufacturing process.
Previously worked with large companies in this role.
Successfully managed projects.
Subject Matter expert for metals and plastics in medical device applications.
** no relocation assistance offered**
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Midwest
Sr. Manufacturing Engineer
Sr. process engineer
Sr. Process engineer NPD
Sr. Equipment Engineer
All 4 positions listed above for vascular expertise- catheters, stents etc.
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Midwest (cont)
Sr. Design engineer (two openings one in Midwest-one on West Coast)
Very high profile role
Pro-E expert
Don’t want a manager or project manager- this is for senior level engineer that is known as the
SUBJECT MATTER EXPERT OR GO-TO PERSON TECHNICAL EXPERT!
Mentor to junior engineers working on designing disposable plastic parts
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Electrical engineering Manager
Previous experience with developing medical device hardware with software applications
Known as Technical expert
Expert with process and product development
Previous people management experience- as they will have direct reports and also work extensively
with cross functional teams.
9-13 yrs of experience
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Lead systems designer
Technical expert- electromechanical focus
Worked with design reviews, DFSS, QSR, Six Sigma, risk mitigation
Approve complex designs.
Mentor junior engineers
********************************************************************************* uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, it also has a click-by-state job bulletin for employers/recruiters to post jobs for free and for job seekers to find jobs for free. The following is a list of new job postings:
Senior CMC Manager NJ
Pharmacist NJ
Clinical Pharmacist NJ
Senior Director Physician Engagement NJ
National Sales Manager Any location
Clinical Trial Manager Cincinnati, OH
Senior Director – Clinical Operations South San Francisco, CA
Associate Director Regulatory Affairs New Jersey
Senior Marketing Manager Austin, TX
Medical Officer with NIH MD
Pls go to our job bulletin job . 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 .
is also launching its one-of-a-kind science eCards. Pls be free to check them out. Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
********************************************************************************* Product Manager, Arthroscopy
Part-time Consulting Position
*********************************************************************************
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Jobs That Crossed My Desk Through Sept. 20, 2009
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Jeff Sprague
TalentMine, LLC
2680 Bishop Dr., Suite 203
San Ramon, CA 94583
Office (925)867-3200 ext. 7388
Cell (925) 768-6521
Email: Jeff.Sprague@
Principal Medical Writer, Medical Communications
Northern NJ
This position in the Medical Communications Group can work remotely for 2 to 3 days a week.
Will be responsible for the preparation of clinical documents for worldwide sub-missions to regulatory authorities and for leading medical writing teams assembled to support large projects. Will support Managers within Medical Communications by providing technical guidance to junior members of the department.
Requirements:
• An advanced degree in Life Sciences - PhD or PharmD preferred.
• 10-plus years in pharmaceutical Research & Development, with at least 5 of those years in senior-Level medical writing.
Responsibilities:
• Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development
• Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team
• In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal medical writing staff
• Will serve as liaison between outside writing sources and will review documents prepared by those outside resources
• Will serve as department's representative for assigned therapy team/working groups, and will participate in determining submission-level timelines
• Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving. Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees
*********************************************
Contact:
Chad Dunavant 866-458-4322 etx. 19021 Cdunavant@
Phil Press 866-458-4322 etx. 19025 Ppress@
Contract Medical Analyst
Southern CA
English must be first language.
Duration of contract is 10 months.
Hourly Rate $60 - $65
First 6-8 weeks will be training period, with 3-4 days on-site and 1-2 days can be done at home. After 6-8-week training period, ½ the work may be done from home.
Requirements:
• Doctorate degree in pharmacy or medicine; PhD in bioscience or equivalent areas
• 2-5 years of drug information experience. Or, other health science degree such as nursing or physician assistant with 7 years of drug information experience in a pharmaceutical setting
• Solid technical writing skills, ability to assess and interpret clinical study data, tabulate and graph data; ability to conduct medical literature searches and evaluation; ability to communicate medical information verbally or in writing; expertise in using MS Word, Excel, PowerPoint, and literature management system e.g. ReferenceManager, EndNote, or ProCite.
Job Description:
• Research and respond to inquiries from health care professionals on a daily basis; conduct literature searches on Amylin and competitor products; utilize OVID or Pub-Med database and/or review clinical study reports for medical teams
• Liaise with key stakeholders, including medical development, medical disclosure, medical research, clinical affairs, regulatory affairs and global safety to obtain information and to ensure data accuracy
• Evaluate published medical literature; provide critical review and editing on the response documents created in-house; attend scientific conferences to strengthen knowledge of company products, technologies, current trends in relevant therapeutic areas
• Manage selected projects independently; create medical backgrounders on company's products; provide training to Med Info team at Customer Support Center (CSC), field sales and potentially field medical teams on relevant scientific information and/or operational processes; provide current medical information, communicate timelines to support medical communications strategies and department initiatives
• Identify issues that are relevant to departmental functions and provides appropriate input and suggestions to project team or manager. Perform other duties assigned by the manager
• Perform all responsibilities in accordance with company Standard Operating Procedures, Good Clinical Practices, and appropriate industry and regulatory guidelines, rules, and regulations; contributes actively toward the satisfactory execution of long-term interdepartmental projects as assigned
• Ensure that initial information regarding adverse events or product complaints of which s/he is made aware during handling of a medical information inquiry is gathered and handled according to FDA mandates and company policies
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Nancy Cody
Director of Staffing
Wirth & Associates
wirth@wirth-
Group VP Quality Assurance - 099-07209-Tcjw
Salary: $200-240,000 + Bonus + Stock Options
MN
Requirements:
BS or higher in Science or Engineering, must have at least 15 years medical device experience in QA leadership, strong lean initiatives experience, exp. in compliance, design controls, audits, global regulatory registrations, etc.
Global leader in Class III medical devices is seeking a qualified individual to head up all aspects of Quality Assurance for a major division.
________________________________________________
Director, Development Quality - 011-06229-TWV
$130K 20% bonus, Relo
Southwest
Reports to: VP
SUPERVISES: Development Quality Engineers and staff
This position is responsible for the overall maintenance and coordination of quality strategies and quality systems programs, activities and issues for Product Development Process (PDP) for software, reagents and instruments. Processes, controls and oversight consistent with an IVD regulated company will be identified and implemented. Has oversight and responsibility for Development Quality Engineering.
____________________________________________________________________________
Technical Supervisor in Quality Assurance, supporting manufacturing Ops.
Florida
_________________________________________________________________________
VP or Sr. Director of Laser Product Development. This person needs to be a very mature research professional that understands large company structures and processes while driving the R&D and product development efforts in medial devices. Expertise in high power laser diodes and optics is a must.
____________________________________________________________________________
Director, Sr. Regulatory - 02-06229-TWV
$150K. 20% bonus, Relo
Southwest
Reports to: VP
Supervises: Director of Regulatory Affairs, Manager Regulatory Compliance
This position is responsible for the overall development, implementation and coordination of regulatory strategies and activities, with a focus on understanding and influencing legislative/regulatory policy issues and assessing the effectiveness of the Quality System.
________________________________________________
Director, Engineering 001P-08309F
Salary to $135k, 15% bonus and 15,000 stock options.
SVP manufacturer in the upper midwest and they are looking for a Director to be responsible for all engineering services and maintenance.
Facility produces SVP's and Lyophilized products for themselves as well as external customers. Plant size is ~150 people.
*************************************************************************************************clairelbarnes@
Title: Senior Director, Quality
Department: Quality
Classification: Full Time, Regular
Supervisor: Vice President, Operations
Direct Reports: Heads of Quality Control, Quality Assurance, Quality Systems & Compliance
Position Summary:
The Senior Director of Quality has responsibility for management and oversight of Solstice’s Quality functions supporting a commercial biological product, including Quality Control, Quality Assurance, and Quality Systems. This position establishes Quality policy within Solstice’s Operations unit, and has final authority for product release decisions. The Sr. Director is also responsible for reporting Quality and Compliance metrics for the Operations unit, and is accountable for ensuring compliance concerns are resolved or escalated to senior Solstice management.
Key Responsibilities:
• Develop, lead and execute a Quality Assurance Strategy, ensuring that the Quality Strategy is appropriate and effective in meeting the business needs
• Continually assess Operations quality and compliance metrics and develop strategic quality objectives
• Maintain a state of compliance with national and international GMP standards pertaining to biological products.
• Oversee development and implementation of standards, methods, and procedures for testing and evaluating the quality and reliability of products
• Develop and integrate GMP and Quality programs into Operations systems and day to day activities
• Develop strategic risk assessment tools and risk management processes
• Interface with corporate partners on all aspects of quality including development and execution of Quality Technical Agreements, as well as on-going quality issues concerning batch release and compliance
• Act as site quality representative for Agency (FDA, EMEA, KFDA, MHRA, and other) interactions including face-to-face meetings and inspections
• Implement strategic goals for regulatory approvals globally.
• Monitor performance against regulatory commitments.
• Exercise judgment in identifying and escalating critical defects/ issues, to assess impacts of defects/issues on supply and for internal and external forecasts.
• Manage multiple projects simultaneously and resolve scheduling and other conflicts in order to meet business objectives
• Regularly identify process improvements and implements changes as needed
• Determine the appropriate staffing levels and capital equipment needs
• Maintain oversight of the QC, QA and QS functions to achieve corporate and department objectives
• Establish department priorities and maintain accountability for delivery of objectives
• Identify talent; coach and mentor staff; create career development and succession plans
• Establish department budget and headcount requirements and maintain oversight of approved budgets
Requirements:
Educational: Bachelor s degree in Science, Engineering, Math or related field. Masters/PhD preferred.
Experience: Minimum of ten years’ progressively responsible and relevant experience with a minimum of 8 years management level experience. Experience must include QA and QC in the biotech or pharmaceutical industry. Must have significant and extensive background in staff management within a Quality organization, and a successful track record implementing quality system process improvements. Must possess strong ability to balance business demands against Quality/Compliance policies.
Skills:
• Thorough knowledge of cGMP requirements for biological product manufacturing
• Strong understanding of regulatory requirements for commercial biological products
• Proven track record with FDA, EMEA, and experience with MHLW preferred
• Strong understanding of risk assessment and risk management fundamentals/tools
• Technical understanding of biological processes
• Team and consensus builder, with definitive and authoritative decision making ability
• Hands-on leader with ability to develop, train and mentor staff
• Strong written and verbal communication skills
• Good presentation skills using a variety of media
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Below is a great opportunity for an HR Coordinator position for a Medical Device Company. The position requires 2 to 4 years of experience. Please only apply if you meet this requirement. This is a entry level position. If interested please contact:
Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
rkhenais@aerotek. com
Human Resources Coordinator Job Description:
Niche-focused medical device leader is seeking a Human Resources Coordinator to serve as HR generalist and support.
Human Resources Coordinator will be supporting all functional areas of the Human Resources Department with a focus on staffing, recruiting and planning but also including compensation and benefits, employee relations, training and development, and legal compliance. Human Resources Coordinator will be responsible for duties such as Internet postings to job sites and company web site, applicant tracking, coordinating interviews with interview panel members, conducting background checks and reference checks on prospective candidates, and conducting new hire paperwork and orientations. HR Coordinator will additionally be responsible for duties like maintaining employee HR files, benefits administration, and more. All duties will be according to Quality System procedures related to this job. This person will also have front-end office duties such as greeting guests and answering phone calls at a low-volume.
Qualified candidate will have 2-4 years of related experience in Human Resources and/or a Human Resources degree and excellent interpersonal skills and the desire to work with individuals in all levels of organization. Will have proficiency in Microsoft Office (Word, Excel, Outlook & PowerPoint) and strong written and verbal communication skills
This is a contract-to- hire opportunity with a leader in medical device technology. Get your foot in the door!
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Hi Everyone, below is a list of jobs that are available in the Medical Device and Pharma industries.
If interested please send your resume to Charles Jo at charlesj@
Below are my the current job openings so please route to your network who may be a fit.
______________________________________________________________________
Clinical
Director/Senior Director, Clinical Operations
Medicines360
San Francisco (Financial District), CA
___________________________________________________________________
Clinical
Head, Clinical Development
CONFIDENTIAL
San Francisco Bay Area
_____________________________________________________________________
Clinical
Clinical Research Associate II
Medicines360
San Francisco (Financial District), CA
________________________________________________________________________
Clinical
Senior Director, Clinical Services (RN/Hospice)
CONFIDENTIAL
San Francisco Bay Area
____________________________________________________________________
Clinical
Director, Clinical Services (RN/Hospice)
CONFIDENTIAL
San Francisco Bay Area
____________________________________________________________________________
Clinical
Supervisor, Clinical Services (RN)
CONFIDENTIAL
San Francisco Bay Area
__________________________________________________________________________
Engineering
Principal Process & Product Development Engineer
Acclarent
Menlo Park, CA
___________________________________________________________________________
Finance & Accounting
Cost Accountant
Acclarent
Menlo Park, CA
___________________________________________________________________________
Healthcare
Physical Therapist
CONFIDENTIAL
East Bay / San Francisco Bay Area
__________________________________________________________________________
IT
IT Specialist (Helpdesk)
Acclarent
Menlo Park, CA
__________________________________________________________________________
Marketing
Marketing Director
Medicines360
San Francisco (Financial District), CA
___--_____-______________________________________________________________
Marketing
Market Analyst
CONFIDENTIAL
San Francisco Bay Area
________________________________________________________________________
Operations
Chief Operating Officer
Medicines360
San Francisco (Financial District), CA
___________________________________________________________________________
Project Management
Project Manager
CONFIDENTIAL
San Francisco Bay Area
_____________________________________________________________________________
Quality
Director, Quality Assurance
Medicines360
San Francisco (Financial District), CA
_________________________________________________________________________________
Quality
Document Control Coordinator
Medicines360
San Francisco (Financial District), CA
_________________________________________________________________________________
Regulatory Affairs
Manager/Director, Regulatory Affairs
CONFIDENTIAL
San Francisco Bay Area
_________________________________________________________________________________
Sales Operations
Senior Sales Operations Financial Analyst
Acclarent
Menlo Park, CA
_________________________________________________________________________________
Sales Operations
Customer Service Manager
Acclarent
Menlo Park, CA
***************************************************************************************************************************
uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, it also has a click-by-state job bulletin for employers/recruiters to post jobs for free and for job seekers to find jobs for free. The following is a list of new job postings:
Pharmacist NJ
Clinical Pharmacist NJ
Senior Director Physician Engagement NJ
National Sales Manager Any location
Clinical Trial Manager Cincinnati, OH
Senior Director – Clinical Operations South San Francisco, CA
Associate Director Regulatory Affairs New Jersey
Senior Marketing Manager Austin, TX
Medical Officer with NIH MD
Pls go to our job bulletin job . 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 at .
is also launching its one-of-a-kind science eCards. Pls be free to check them out. We wish you all lots of successes.
*************************************************************************************************
David Obad
Managing Partner
NCompass Recruiting
415.738.7878 x104 - Office
415.738.7878 - Facsimile
866.949.7878 - Toll Free
"Helping Navigate Your Medical Device Career"
We are in search of a Principal Test Engineer for a 30 person medical device start-up located in Palo Alto. This Test Engineer will need experience in the design and deployment of manufacturing test systems for implanted medical devices. The bullet points below outline the minimum requirements and attached below is the full job description.
- Minimum 5 years experience in development of automated test equipment (ATE) for class-3
implantable medical devices
- Proven circuit and system design skills for ATE system
The ideal candidate will have experience leading the development of manual and automated test solutions for both design verification and manufacturing tests.
If you know of someone who would be interested in hearing more please feel free to pass along my contact information.
Job Title: Principal Test Engineer
Job Summary
Design and deployment of manufacturing test systems for implanted medical device. Investigation and resolution of product and process related failures.
Essential Duties and Responsibilities
Lead the development of manual and automated test solutions for both design verification and manufacturing tests.
Plan for both short- and long-range test strategies considering tradeoffs such as alternative technologies, architectures, resources, schedules and budgets.
Lead the implementation of the test plans from requirement development, design, verification, validation, release, and sustaining.
Manage vendors effectively by establishing good working relationships, anticipating problems and providing constructive solutions as required.
Conduct development activities in compliance with company’s design control operating procedures.
Recruit and staff talents to source test projects to meeting company’s goals.
Mentor junior-level engineers
Position Qualification Requirement
Minimum a degree in BSEE or equivalent
Minimum 5 years experience in development of automated test equipment(ATE) for class-3 implantable medical devices
Minimum 10 years of design experience in ATE or HW engineering
Proven circuit and system design skills for ATE system
· Fluent in concepts, practices and procedures for the field of medical device ATE systems
· Fluent in CAD tools
· Ability to apply extensive knowledge and experience to accomplish goals
· Familiarity with uP-based embedded system designs
· Familiarity with RF systems
Excellent teamwork, verbal and writing communications and interpersonal skills
Software skills in LabView, C++, C, C# a strong plus
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Please submit resume to hr@
Title: Market Research Analyst – San Francisco with Medicines360
Reports To: Marketing Consultant
Status: 3 month Contract/Full time
MISSION Medicines360 is a non-profit pharmaceutical company that addresses unmet needs of women and children by developing innovative, affordable and sustainable medical solutions.
POSITION SUMMARY
As part of the Marketing team, prepare the organization for the successful Marketing of the company’s first product in the field of Women’s Health.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned
Create Internal Data Knowledge base:
Build a comprehensive understanding of the market place of interest, including customer segmentation, providers (physicians & nurse practitioner) the institution that provide the service both in the public and private sectors, and the basics of the reimbursement and payer mechanisms.
Goal Setting and Marketing Plan:
1. Participate in the development of an Excel-based market model for both public and private sectors for the next 10 years, and set realistic SOM goals over time.
2. Contribute to development of a detailed Marketing Plan and Expense Budget that will serve as our roadmap for key activities.
EDUCATION and/or EXPERIENCE
MBA (Marketing major preferred) and a degree in life science required. Previous knowledge of Family Planning or Women’s Health areas highly desirable.
Knowledge of Pharmaceutical Market/Sales data bases.
Highly organized with strong analytical skills and ability to identify, obtain and manage voluminous and complex specify type of data.
Conduct and/or managed primary market research, both quantitative and qualitative
Excellent inter-personal skills with an ability to "connect" easily with people in one-on-one, group and telephone settings.
Mature, energetic with a self-starting, "let’s roll up our sleeves" attitude, which is especially important in a small but growing organization.
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Jobs That Crossed My Desk Through Sept. 13, 2009
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Contact person:
Thomas Hynds
Director, Clinical Operations
Research Dynamics Consulting Group
Pittsford, NY 14534
Phone (585)381-1350 ext 234
Fthynds@
I have heard of this opportunity & wanted to spread the word. If you know of someone who is qualified, he/she should contact Tom directly.
We are looking for an experienced CRA who is available to work, full time at the Sponsor's SF office for approximately 4 months, starting immediately. The assignment will require overseeing start up activities & regional monitoring for a Ph 3 program.
Experience in study start up activities & at least 4 yrs monitoring experience are required.
Former experience with contraceptive studies is a real plus.
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Contact Ronald Coelyn
E-mail: rcoelyn@
Phone: 817-424-3652
web:
Our Firm is currently working on several executive search projects for lifescience industry clients. We would value your help in identifying some exceptional candidates for one very special client in particular.
The Company's mission is to reduce the trauma associated with traditional open heart valve replacement surgery. The technology involves the development of percutaneous aortic valve replacement (PAVR) and transapical aortic valve replacement (TAVR) systems.
We have performed several senior level projects for this client, a company that is growing very rapidly, and our relationship is unique. So, when they asked if we could identify some candidates for a most important, albeit junior level position, we agreed.
Quality Systems Engineer – Southern California
The Quality Systems Engineer is a key member of the Company's manufacturing/operations team. He/she will develop documentation control and tracking systems that are both effective and cost efficient; create a quality culture that focuses on customer satisfaction and quality planning versus problem resolution and crisis management; develop quality systems to a minimum of ISO 9000 certification level; etc. He/she will have:
• At least 10 years experience in quality function in a pharmaceutical, biological and or medical device environment, responsible for developing and implementing quality systems
• Demonstrated ability to develop strategic integrated plans to mitigate compliance gaps effectively
• Experience working in a regulated environment required: GMPs, GLP's an GCP's
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) is required
• Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards
As a more junior position the anticipated base salary for the candidate-of-choice will be approximately $100,000, or more, with a performance incentive bonus of about 20%.
The position will be located at the Company's manufacturing facility which is in Southern California.
We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals; and finally, people whose track record of accomplishments and contributions are unambiguously clear.
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Interested candidates should send a motivation letter and CV to the attention of
Brian B. RUDKIN:
PostDoc@ens‐lyon.fr
Brian B. Rudkin, PhD
Head, Differentiation & Cell Cycle Group
Laboratoire de Biologie Moleculaire de la Cellule
UMR 5239 CNRS/ENS Lyon/Université Lyon 1/HCL
IFR 128 "BioSciences Lyon-Gerland"
Ecole Normale Superieure de Lyon
46, allée d¹Italie
69364 Lyon cedex 07
France
Tel : +33.4.72.72.81.96
Fax : +33.4.72.72.80.80
Mobile : +33.6.10.28.08.32
e-mail : bbrudkin@ens-lyon.fr
Deadline for application: September 15, 2009
Web : ens-lyon.fr/LBMC
POST DOCTORAL POSITION
European adventure in functional selection to identify key proteins involved in
self‐renewal of embryonic stem cells.
In the context of a 3M € European collaborative grant “BEST STEM CELL”, involving 7
teams over three years, your role will be to participate in the identification and
characterisation of targets of biologically‐active peptide aptamers selected for their
capacity to stimulate self‐renewal of human embryonic stem cells. This will be
achieved by implementation of yeast two hybrid approaches, complemented with
analysis and validation of gene function in selected cellular systems (cf de Chassey et
al. (2007) Mol. Cell. Proteomics 6:451‐459).
The successful candidate for this three year position will have solid knowledge of
techniques in molecular and cellular biology for evaluating gene function and
signalling pathways (e.g. cloning, siRNA, mammalian cell culture, Flow cytometry,
microscopy, expression, …) and, ideally, be experienced in Yeast Two‐hybrid.
Experience with in vitro analysis of protein‐protein interactions (purification,
Biacore, …) would be considered a plus.
Salary level will be based on experience. Start date is on or before October 1, 2009.
The Ecole Normale Supérieure de Lyon is one of France’s top academic research
institutions, located in a vibrant technology cluster with world‐class laboratories and
technology platforms. In addition to being renowned for its innovative cuisine, Lyon
is one of the most dynamic “user‐friendly” cities in France and Europe.
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Please send resume as an attachment to wd_darshana@ with
"Catheter Engineer" in the subject line.
Darshana
Darshana Varia Nadkarni, Ph.D.
Medical Device Recruiter
Updates on Twitter @DarshanaN
Catheter Engineer
There is an immediate job opening for a Catheter Engineer with a company
located in San Jose. Company found by a veteran leader with a great track
record of success, is working on developing pacemaker and neuro-stimulation
leads. Requirements include Bachelors in Mechanical Engineering plus
minimum 5 years hands-on catheter design experience, and familiarity with
polymers extrusion processes. Experience with electrophysiology catheters,
a huge plus. Ideal candidate will have demonstrated ability to contribute
in all phases of new product development including ideation, concept
development, detailed engineering, and design for manufacturing. This is an
exciting opportunity in early stage company with solid funding, and secure
IP.
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Please contact Julie@ for details or call 650-520-3433 (prefer email contact first).
A Client is looking for a clin ops person at the Sr Clin Assistant to SCRA level. Description is below in case you know of anyone. It can be a full time job or a consultant (at least 35 hrsw/week on site)…
In House Clinical Operations Position: The company is a start-up in South San Francisco and some of the work needed includes working w/ the sites on contracts and budgets; coordinating drug supply shipments; following up with investigator or patient requests; making sure all documentation is in order; reading and reviewing documents. Works closely with the Director of Clinical Operations.
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Contact person:
Thomas Hynds
Director, Clinical Operations
Research Dynamics Consulting Group
Pittsford, NY 14534
Phone (585)381-1350 ext 234
Fthynds@
We are looking for an experienced CRA who is available to work, full time at the Sponsor's SF office for approximately 4 months, starting immediately. The assignment will require overseeing start up activities & regional monitoring for a Ph 3 program.
Experience in study start up activities & at least 4 yrs monitoring experience are required.
Former experience with contraceptive studies is a real plus.
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Carol Nast
President, Enterprise Catalyst Group
cnast@
Ph: 650 208 3596
Fax: 650 327 0926
Mechanical Engineer IV
Req Number: D09-023
Employment Type: Full Time
Location(s): Hercules CA
Job Department: R&D
Hiring Manager: Don Bartling
Recruiter: Regina Finuliar
Career Field: Research
Education: Advanced degree in Mechanical Engineering
Skills and Experience:
Education: Advanced degree in Mechanical, Bio-Engineering, and/or related Engineering discipline.
Experience: 10+ years of product development experience in Medical Device Industry or equivalent. Strong background in Bio-Mechanical Systems,
Reliability Engineering, Instrumentation, and/or Integration of complex bio-medical systems. Knowledge of principles of separation science, HPLC and analytical instrumentation, and method development preferred.
Skills: Able to work independently as well as within team environment.
Provide design solutions to mechanical problems and generate engineering concepts and precision drawings. Work with outside vendors to create prototypes. Able to effectively communicate to all levels of the organization and act as a key member of cross-functional project team. Able to provide technical leadership and mentoring less experienced staff.
Proficient knowledge with QSR and design control processes, strong
documentation skills (e.g. ISO13485).
Duties and Responsibilities:
Position Responsibilities: The engineer's primary responsibilities will be: 1) Specify, design, develop, and execute engineering solutions (Chemistry, Electrical, and Mechanical) to meet product development objectives; 2)Act as key functional expert in coordinating engineering activities for testing and
improving product reliability, and performance; 3) Contribute as part of a cross-functional team effort towards the design and integration of the system to meet safety, effectiveness, and reliability and cost targets; and 4) Carry out engineering/scientific calculations, specifications and mentor more junior staff to deliver timely, accurate and functional solutions to project team.
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We are currently offering a Post Doctoral position in the context of a well funded EU project on stem cells and would appreciate if you could post and circulate the following announcement.
Brian B. RUDKIN
Brian B. Rudkin, PhD
Head, Differentiation & Cell Cycle Group
Laboratoire de Biologie Moleculaire de la Cellule
UMR 5239 CNRS/ENS Lyon/Université Lyon 1/HCL
IFR 128 "BioSciences Lyon-Gerland"
Ecole Normale Superieure de Lyon
46, allée d¹Italie
69364 Lyon cedex 07
France
Tel : +33.4.72.72.81.96
Fax : +33.4.72.72.80.80
Mobile : +33.6.10.28.08.32
e-mail : bbrudkin@ens-lyon.fr
Web : ens-lyon.fr/LBMC
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Below is our update on positions we are currently working on in medical device. Most positions are located in the SF bay area unless noted otherwise. You are welcome to pass this along to anyone that may be interested. If you have any questions, please feel free to get in touch anytime. Also, you may review the detailed job descriptions posted on our site at .
Most Urgent Positions:
▪ VP of CA, RA
▪ Director of R&D
▪ Director of Global Marketing
______________________________________________________________________________
REGULATORY, QUALITY & CLINICAL AFFAIRS
VP of Clinical & Regulatory Affairs (S. CA)
§ 15+ yrs experience in medical device industry
§ 10+ yrs experience clinical trials management
§ Regulatory Affairs experience (510K)
§ Startup experience
§ Strong management and leadership skills
________________________________________________________________________________
Principal International Regulatory Affairs Specialist
▪ Minimum of 5 years experience in US and OUS class III medical device Regulatory Affairs management and execution
▪ Strong knowledge of IDE, PMA, 510(k), ISO, and QSR requirements required
▪ Working knowledge of US and OUS clinical research regulations and techniques
▪ Demonstrated ability to effectively implement and manage complex global regulatory program
▪ Bachelors Degree in scientific or health related field required
_______________________________________________________________
Sr. Global Regulatory Affairs Director (S. CA)
▪ Minimum of 10+ years experience in US and OUS medical device Regulatory Affairs management and execution
▪ Emphasis is on international RA management
▪ Strong management skills, at least 3 yrs of senior management experience
▪ Bachelors Degree in scientific or health related field
________________________________________________________________________________
R&D, MANUFACTURING & OPERATIONS ROLES
Director of R&D
§ BSME, MSME preferred
§ Strong catheter development experience
§ 10+ yrs experience in medical device industry
§ At least 5 years of management experience, strong management & leadership skills are required
________________________________________________________________________________
Sr. R&D Catheter Engineer
§ BSME
§ Strong catheter design and development experience
§ 10+ yrs experience in medical device industry
§ At least 5 years of management experience
________________________________________________________________________________
R&D Scientist
§ BS Analytical Chemistry or related fields
§ Medical device industry experience
§ Experience with glucose monitoring a major plus
§ Strength in numerical analysis, chemometrics and data mining
________________________________________________________________________________
Customer Service Manager
§ 7 - 10+ years experience as a customer service manager
§ SAP experience
§ Pro-active, problem solving abilities, strong mentoring and leadership skills, performance management
§ Exceptional communication skills
§ ACD, call center experience
________________________________________________________________________________
Customer Care Analyst
§ BA Degree or equivalent experience.
§ 3 years of transactional accounting experience and five years ERP experience with emphasis on special pricing and transacting credits and debits.
§ Solid analytical and problem solving skills. Learn and adapt quickly.
§ Proficient in SAP (or equivalent ERP experience)
§ Microsoft Office (strong emphasis in Excel)
§ Excellent written and verbal communication skills.
§ Highly organized with the ability to manage daily tasks and special projects while adhering to deadlines.
§ Experience working with field sales reps and customers is preferred.
________________________________________________________________________________
SALES, MARKETING & BUSINESS DEVELOPMENT
Director of Global Marketing
§ BA/BS degree, MBA would be a plus
§ 10+ yrs marketing experience
§ Cardiovascular device experience
§ Proven track record of strong management and leadership skills
§ 30% - 50% travel
________________________________________________________________________________
Product Manager
▪ 2+ years of product management experience in medical device industry
▪ BA,BS degree, MBA a plus
▪ Travel 30%
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INTERESTED PARTIES SHOULD ADDRESS QUESTIONS AND SEND SHORT CV TO : HR@
Senior technician assay development—Bay Area (shared by industry colleague)
Kalinex Inc., a startup company based in the San Francisco Bay Area that is pushing the frontiers of bio-sensing to meet nucleic acid detection needs for life science R&D, food safety testing, and medical diagnostics with the potential to make global impact. We are seeking an experienced technician, with expertise in assays, in particular qPCR, to join our team of biochemists and engineers to work in the lab to trouble shoot assays. Candidate must thrive in an innovative, results-focused environment and be self-starting. Familiarity with oligonucleotide primer design software preferred. Job site will be Molecular Foundry, Lawrence Berkeley Lab and east bay Kalinex incubator space. Annual salary 50-85K depending upon level of experience. *****************************************************************************************************************************************************
I joined Crawford Communications Group as vice president of new business this winter and currently we are looking for a student intern to help us with some demand generation activities. I would appreciate your help in finding this talented individual. Read on!
Please provide resume and samples of writing and any creative projects. Send to talent@ for consideration.
Student Intern Wanted (unpaid position with potential upside in 2010)
We are looking for a student intern or recent grad that is hungry to learn and will gain excellent work experience with a growing company. This intern position is targeted toward someone who is seeking real world marketing and sales experience. No coffee runs, filing or copying. We look forward to being a great reference for a great project.
Crawford Communications Group is a marketing and communications firm providing professional services to high technology Fortune 1000 companies. We work with clients who have a business critical initiative to deliver with insufficient internal expertise, resources or bandwidth. Crawford provides project consulting expertise for strategy and execution of initiatives, campaigns, launches and programs.
Job Responsibilities
· Demand Generation programs for Crawford Communications Group
· Develop sales campaigns in
· General sales and marketing support and coordination
· Support VP of New Business
Requirements--Must have
· Excellent writing skills
· Marketing course work or subject focus
· This a part time schedule -15-20 hour/week with flexibility. 90 days to start.
Compensation
· This is an unpaid internship initially with some potential upside in 2010
Details here
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IF YOUR BACKGROUND FITS THIS DESCRIPTION, PLEASE CONTACT HEATHER BROWN, SENIOR RECRUITER, AT ADVANCED CLINICAL SERVICES:
HEATHER BROWN
SENIOR RECRUITER
ADVANCED CLINICAL SERVICES
650 TOWNSEND STREET, SUITE 352
SAN FRANCISCO, CA 94103
DIRECT: (415) 358-2409
CELL: (415) 793-0435
FAX: (415) 621-6122
HBROWN@
PART-TIME MEDICAL WRITER
Berkeley, CA
WE ARE LOOKING FOR A PART-TIME, ON-SITE MEDICAL WRITER WITH SPECIFIC EXPERIENCE IN VACCINES.
Responsibilities
• Write high-quality clinical documents
• Identify the customers for each document, and formulate and convey key messages clearly and concisely
• Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines
• Use appropriate stylistic conventions
Requirements
• Minimum of 5 years industry experience as a medical writer
• Specific vaccines experience
• Familiar with the drug development process and regulatory documentation
• Able to gather and synthesize large amounts of data
• Demonstrated ability to write clear, concise, and effective drug development documents
• Good team player; excellent written and verbal communication skills, and able to work well with others
• Able to meet timelines without compromising document quality
• Able to ensure consistency within and across documents
Competency in relevant software applications
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Contact: Resumes and questions should be sent to anita@pse-, or phone Anita at 215-456-9066.
Anita Zalewski
PSE Co.
A Talent Resource
Tel: 215-456-9055
Fax: 215-565-2727
anita@pse-
pse-
Contract Medical Communications Scientist
Delaware Valley
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive client products in the US.
Major Responsibilities
• Prepare regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
• Critically assess, interpret, and accurately summarize medical data.
• Contribute to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
• Promote and exploit global working in the preparation of clinical contributions to regulatory dossiers.
• Provide innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
• Interpret and monitor current and emerging communication issues and guidelines.
• Manage contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Minimum Requirements
• Baccalaureate degree in biomedical discipline. - 3-5 years work experience
• Knowledge of the drug development process and human pathophysiology and diseases.
• Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
• Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management.
• Knowledge of regulatory requirements and guidelines and standards.
• Influencing, interpersonal skills.
• Ability to travel nationally and internationally
Preferred Background
• Advanced biomedical degree
• Budget and resource management skills
• Knowledge of competitors and competitor products
Hours: Mon - Fri; 8:30am - 4:45pm
Contract term: 09/21/10 (with potential for extensions)
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uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, it also has a click-by-state job bulletin for employers/recruiters to post jobs for free and for job seekers to find jobs for free. The following is a list of new job postings:
Senior Director – Clinical Operations South San Francisco, CA
National Sales Manager Any location
Clinical Trial Manager Cincinnati, OH
Associate Director Regulatory Affairs New Jersey
Senior Marketing Manager Austin, TX
Medical Officer with NIH MD
Pls go to our job bulletin job . 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 at .
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Other Information for Those in Transition
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Upcoming Bioscience Business and Marketing Courses in the fall at UCSC Extension at the new location in Santa Clara near intersection of 101 and Bowers…please help us promote these courses beyond those who have taken them already. There’s little information about these courses developed specifically for working professionals in the life science industry. These two days of intensive classroom work followed by 2 months of work done at student’s home location allows for participants who come from outside the Bay Area on business and add on two days and take a top rated course from experts in the field at an affordable price.
October 8-9: BIOSCIENCE BUSINESS AND MARKETING ESSENTIALS
The bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social and political challenges impose constraints that impact every aspect of the business. This course helps participants gain: a practical understanding of the bioscience industry landscape, key business drivers and challenges; insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and hands-on experience implementing important bioscience business processes that are essential to success within the industry. Presented by UCSC Extension in Silicon Valley, Santa Clara, CA. For more information: See ucsc-extension.edu/biobusiness.
December 3-4, BIOSCIENCE BUSINESS DEVELOPMENT: BUILDING VALUE
UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev
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Biotech Bay Career Fair, Tuesday Afternoon and Early Evening, Oct. 13, 2009
Event: Biotech Bay Career Fair
Location: San Francisco Airport Marriott
Date and Time: Tuesday, October 13, 2009; 2pm to 7pm
Click here for directions
Register at
Event Description
Positions in Biotech * Pharmaceutical * Medical Device & Diagnostics
Looking for a new job? Networking with industry peers in an ever-changing work environment?
Attend the Biotech Bay Career Fair!
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?
Scroll to the bottom of the pages to see a list of exhibiting companies. 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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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 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.
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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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See free downloadable annual Salary Survey from Contract Pharma at
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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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