Jobs That Crossed My Desk Through Sept
Jobs That Crosssed My Desk Through Nov. 1, 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.
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Christopher Corey
> Executive Recruiter
> Search Group of San Diego
> 858-217-5582
> chris@sgsd.jobs
>
Principal Scientist, Pharmaceutical Sciences
Formulation Development
The Principal Scientist will plan, direct, and execute formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization with focus on controlled-release ocular implants. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.
The essential components of this position are in-depth understanding of pharmaceutical formulation principles, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,
◦Provide scientific and technical leadership for pharmaceutical product development projects and in general, Global Pharmaceutical Sciences.
◦Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
◦Represent department at project team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
◦Apply current CMC regulatory requirements and guidances to support global registration of new products.
◦Exhibit leadership skills that result in good performance and career development of junior staff.
◦Have excellent oral and written communication skills.
Qualifications
This position requires a Ph.D.-level education preferably in pharmaceutical sciences or chemical engineering with eight years of applicable experience with emerging national recognition, which is defined as having accomplished three or more of the following:
◦scientific findings that have the potential to open new markets and market opportunities and will add to the company's technology base
◦patents in the area of specialization
◦scientific publications in areas of specialization
◦has been an invited speaker at national meetings or short courses
◦has been a reviewer for manuscripts submitted for publication
Must be able to function as a CMC team leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations. Knowledge of fundamental applications of statistics is preferred.
(Job Number: 090445)
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Contact: John Colantoni/JWC Associates
Phones: 732-792-2933 and 609-921-9090
E-mail: jwchh500@
STAFF ENGINEER-MECHANICAL ENGINEERING, Central NJ
- Function as a Subject Matter Expert in mechanical systems used in Bio Pharmaceuticals, with an extensive knowledge of HVAC, Utility and Compendia Water Systems.
- Provide technical leadership on standards for engineering and engineering related topics, across the organization Provide strategic guidance and expert technical support for capital investments and for ongoing operations.
MAJOR DUTIES
- Responsible to make Engineering more effective and efficient by translating technical knowledge and lessons learned into meaningful direction to the engineering community across the organization.
- Serve as an expert knowledge resource to the internal customers.
- Accountable for the technical content and timely delivery of all discipline related standards and directives and to harmonize standards for technical solutions, equipment & CQV CSV across various groups.
- Provide project specific technical support all stages of capital projects.
- Accountable to ensure that the design meets its intent and it complies with the Design Standards.
EXPERIENCE DESIRED
- Understands and embraces concept of Engineering as knowledge based service.
- Experience with facility types core to the business, such as Bulk Chemical & Biologics API, OSD, Aseptic processes in commercial manufacturing, clinical supply and R&D environment.
- Strong knowledge of fundamental design principles for cGMP compliance in Pharmaceutical Operations and supporting systems.
- Demonstrated understanding of business needs, risks, applicable codes and regulatory implications of the technical choices.
- Strong understanding of the role of engineering in the execution of projects with demonstrated ability to maintain active participation.
- Ability to lead people in multi disciplinary engineering teams Proven ability to communicate clearly and directly at all levels, with both integrity and discretion.
- Partner with Stakeholders to balance business objectives with scope, cost, and schedule requirements.
- Effectively utilizes relationships with internal and external stakeholders to leverage best practices and achieve project objectives.
OTHER
- BS in Engineering with 7+ years experience in bio pharmaceuticals or related industry is required. MS in Engineering, PE preferred Individual contributor. ME preferred
- 25 percent Travel with overnight stays.
Salary in the six-figures, bonus, and relocation. Position is based in New Jersey
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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, also has a click-by-state job bulletin (job) 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:
JD Edwards CSV Consultants
Senior Pathlogist with MedImmune MD
Scientist with MedImmune MD
Senior Account Manager San Francisco
Medical Director San Francisco
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.
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Here is a position for a Senior Regulatory Affairs Associate in Colorado.
If you are interested, contact
Melissa Morof
Clinical Research Recruiter
Kelly Scientific Resources
Telephone: 248-244-5499
Toll Free: 877-269-5401
Fax: 248-244-4172
E-mail: MOROFME@
clinical
Position Description:
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting direct hire full-time Senior Regulatory Affairs Associate position available in the Fort Collins, Colorado area.
Purpose and Scope
Under minimal supervision, perform all functions pertaining to domestic and international regulatory submissions including review of documentation, preparation of documents for electronic or paper filing, compilation of submissions, and review/approval of final submissions.
Essential Duties & Responsibilities
• Serve as regulatory representative on project teams. Offer regulatory opinions with consultation from senior regulatory management.
• Coordinate with personnel from other departments to obtain data/documentation for submissions and maintain timelines.
• With supervision from Regulatory Manager, act as liaison with regulatory agencies.
• Review draft investigational and commercial labeling artwork.
• Assist Regulatory Manager as requested.
• Perform regulatory research tasks as requested.
• Assist in or maintain product applications (INDs, NDAs, ANDAs).
• Maintain electronic document management system as required.
• Conform to regulatory department standards.
• Prepare and assist in preparation of domestic and international regulatory submissions.
• Provide training and guidance to other staff members when needed.
• Provide review of informed consents and protocols.
• Maintain up-to-date knowledge of current guidance and regulations.
• Perform various other duties as assigned.
Knowledge, Skills & Abilities
• Demonstrated knowledge of MS Office, Adobe Framemaker and Adobe Reader/Writer.
• Excellent writing and organizational skills.
• Ability to work independently.
• Ability to coordinate information from various internal and external disciplines.
• Ability to understand regulatory and technical concepts and requirements.
• Ability to perform multiple tasks on several projects.
• Ability to prepare written summaries of technical data suitable for inclusion in regulatory submissions.
• Ability to understand, and comply with domestic and international regulatory requirements.
• Ability to follow specific directions and to request instructions for complex tasks.
Education & Experience
• Bachelor's degree in related field.
• Four or more years experience in the pharmaceutical/biologic industry with knowledge of preparing and submitting regulatory dossiers/applications to regulatory agencies.
Benefits & Compensation
• 65 – 85 K per year plus benefits
• Competitive health care package
• GREAT vacation and paid time off
• Relocation assistance provided
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. We provide clinical research and scientific staffing to pharmaceutical, biotechnology, medical device and contract research organizations across the US. Kelly Services is an Equal Opportunity Employer.
To be immediately considered for this position, please e-mail morofme@ or call 1-877-269-5401!
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Jobs listed for Prometheus Labs in San Diego. Go to
|Title / Description |Company |Location |Date Posted |
|Technical Sales Specialist |Prometheus Laboratories |, US |10/30/2009 |
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|For further information about our current Technical| | |View full description |
|Sales Specialist openings, click on "Apply Now" and| | | |
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|Sr. Technical Operations Scientist II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Responsible for developing and | | |View full description |
|troubleshooting assays and procedures to transfer | | | |
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|Sr. Technical Operations Associate II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Assists with the transfer of new and | | |View full description |
|existing assays from Research & Development to Lab | | | |
|Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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|Sr. Technical Operations Associate II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Assists with the transfer of new and | | |View full description |
|existing assays from Research & Development to Lab | | | |
|Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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|Sr. Regulatory Affairs Associate |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Responsible for coordinating the activities| | |View full description |
|to support maintenance of current products, | | | |
|successful regulatory fi... | | |Save to MyBeakerBoard |
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|Sr. Manager, Clinical Operations |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Position responsible for implementation, | | |View full description |
|management and coordination of diagnostic and | | | |
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|Sample Bank Manager |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
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|SUMMARY Responsible for managing and tracking the | | |View full description |
|physical receipt, storage and retrieval of samples,| | | |
|as well as the ass... | | |Save to MyBeakerBoard |
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|Research Associate ( Temporary) |Prometheus Laboratories |, US |10/30/2009 |
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|SUMMARY Assists with the development of diagnostic | | |View full description |
|assays and analytical methods for the transfer of | | | |
|technology to the C... | | |Save to MyBeakerBoard |
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|Research Associate ( Temporary) |Prometheus Laboratories |, US |10/30/2009 |
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|SUMMARY Assists with the development of diagnostic | | |View full description |
|assays and analytical methods for the transfer of | | | |
|technology to the C... | | |Save to MyBeakerBoard |
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|Research Associate ( Temporary) |Prometheus Laboratories |, US |10/30/2009 |
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|SUMMARY Assists with the development of diagnostic | | |View full description |
|assays and analytical methods for the transfer of | | | |
|technology to the C... | | |Save to MyBeakerBoard |
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|SUMMARY Assists with the development of diagnostic assays and analytical methods for the transfer of technology to the C... |
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|Research Associate ( Temporary) |
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|SUMMARY Assists with the development of diagnostic assays and analytical methods for the transfer of technology to the C... |
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|Prometheus Laboratories |
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|Product Manager |
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|Summary: Management, design, and production of planned marketing programs of the Prometheus Celiac testing including Cel... |
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|Prometheus Laboratories |
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|San Diego, CA US |
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|Medical Accounts Representative II |
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|SUMMARY Telephonically and electronically Interfaces with internal and external parties to collect payment on Prometheus... |
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|Prometheus Laboratories |
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|San Diego, CA US |
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|Medical Accounts Representative II |
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|SUMMARY Telephonically and electronically Interfaces with internal and external parties to collect payment on Prometheus... |
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|Prometheus Laboratories |
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|San Diego, CA US |
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|Diagnostic Quality Analyst I |
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|SUMMARY Performs quality control related activities supporting clinical laboratory testing. ESSENTIAL DUTIES AND RESPONS... |
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|Prometheus Laboratories |
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|Clinical Lab Technician II |
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|SUMMARY Performs pre-analytical and analytical procedures for patient testing. ESSENTIAL DUTIES AND RESPONSIBILITIES inc... |
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|Prometheus Laboratories |
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|San Diego, CA US |
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|Clinical Lab Scientist II |
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|SUMMARY Performs pre-analytical and analytical testing, interprets and reports patient results to ordering physicians. E... |
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|Prometheus Laboratories |
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|San Diego, CA US |
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|Analyst/Sr Analyst Sales Ops |
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|Prometheus Laboratories |
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|San Diego, CA US |
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Contact:
All inquiries should come to Carol Howard, Sr. Recruiter, Assent Consulting. (408) 540-4915 or carol@ 10054 Pasadena Avenue, Cupertino, CA 95014, .
Clinical Study Report Project Manager
San Francisco Bay Area
6-month, full-time on-site contract in San Francisco
SUMMARY:
Coordinate the various aspects of preparing the Clinical Study Report (CSR) for regulatory submission in a timely manner
DUTIES & RESPONSIBILITIES:
* Coordinate the outsourced components of the study report
* Diplomatically manage the production deadlines of the report generation team
* Manage versions, editing, and timelines
REQUIREMENTS:
* Familiar with all aspects of the CSR
* Medical writing and CSR generation expert
* Strong project management background
* Four-year degree
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Clinical Document Quality Check Contractor
San Francisco Bay Area
This position is a 6-month, full-time, on-site contract.
The contractor will be responsible for reviewing up to 25 data tables per day, as well as reviewing/editing Clinical Study Reports.
Candidates should have knowledge of data tables, CSRs, and Regulatory Documents. Candidates must be on-site in Mountain View, CA, location.
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Contact:
Interested candidates may apply online at .
Clinical Content Specialist (Drug Information)
Greenwood Village, CO
Title: Clinical Content Specialist (Drug Information)-PUB00002158
Job: Publishing/Editorial
Primary Location: US-CO-Greenwood Village
Organization: Healthcare US
Schedule: Full time
Education Level: Bachelor's Degree (±16 years)
Job Type: Standard
Shift: Day Job
Employee Status: Regular
Description:
The healthcare business of Thomson Reuters provides insights -- information, benchmarks, and analysis--that enable organizations to manage costs, improve performance, and enhance the quality of healthcare. The Clinical Content Specialist is responsible for content creation, review, and maintenance, utilizing multiple complex sources of information and editorial technology.
• Applies critical literature evaluation skills, knowledge of pharmacokinetics, pharmacodynamics, disease state and therapeutic endpoints to accurately assess efficacy and/or comparative efficacy of drug therapy
• Identifies, evaluates and utilizes appropriate references/literature to determine, support or reject an appropriate drug dose based on patient-specific parameters and based on definitive criteria and/or outcomes
• Utilizes substance-specific pharmacokinetic and pharmacodynamic knowledge to identify or predict a potential mechanism for a drug interaction, adverse effect, therapeutic effect or toxic effect
• Synthesizes complex information from multiple, sometimes conflicting, sources to form a conclusion
• Researches and resolves editorial inquiries requiring domain expertise
• Performs quality control testing of Healthcare products; assists with development of quality assurance protocols
• Applies critical literature evaluation skills to develop and implement editorial policies and style guidelines
• Keeps up-to-date on current practices within specialty content area(s); maintains awareness of current controversies, issues and developments
• May provide support to other departments and business units as required
• Reviews written content and provides feedback to writers to improve quality of content
Qualifications:
• Demonstrated ability to apply clinical knowledge and experience in critical thinking and problem-solving; ability to recognize discrepancies in data and interpret and draw inferences from complex data
• Ability to solve problems, independently organize work and perform multiple tasks
• Demonstrated ability to communicate with management and other team members
• Demonstrated expertise in critical literature evaluation skills
• Solid knowledge of Internet search engines and strategies
• Demonstrated writing ability and knowledge of grammar, punctuation and sentence structure; computer literacy; knowledge of word processing and relational database applications
• BS Degree in Pharmacy plus 2 years related clinical experience or PharmD (residency preferred). Active pharmacy license required(may be held in any of the 50 states)
Thomson Reuters employees take pride in providing our customers around the world with information that is timely, accurate, unbiased and trusted. We have a profound respect for the professions and customers we serve and define our success in terms of their success. Our work environment is dynamic, innovative and entrepreneurial. We have a result-oriented culture that demands excellence, agility, and the desire to move quickly and precisely to seize opportunities. Our environment is both challenging and supportive - we give employees the opportunity to develop their skills and do their best work.
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Please contact me if you know of anyone who could be a good fit.
Julie
Managing Director
JGB BioPharma Consulting
650-520-3433
I am working for 2 local bay area clients that would like to fill full time positions (Clinical Research Associate/CRA to Senior CRA). One is in-house based (so little travel and no direct monitoring) and the second includes both in-house work and monitoring (some USA travel).
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Contact:
Matt Soloperto
Search Consultant
Clockwork Consulting, LLC
162 Sidney Street
Cambridge, MA 02139
ph: 617.225.0397
fax: 617.225.0308
msoloperto@
Senior Manager/Associate Director, Medical Writing – Cambridge, MA
Type of Job: Direct hire; permanent role
Compensation: Will discuss with each interested party
General Description:
Management of several writers comprising a subdivision of the Medical Writing Department. Reports to Director of Medical Writing. Writes documents associated with clinical trials. Forecasts and fills resource needs for projects under his/her supervision.
Detailed Description and Job Scope:
Supervises Writers and Editors. Reviews work of Medical Writers and/or Editors and assists in their professional development. Models rigorous and disciplined approaches to medical writing. Communicates a philosophy which strikes a proper balance between high production and high quality. Helps writers to utilize their strengths and work around their weaknesses.
Responsible for resource planning and allocation. This includes forecasting of medical writing needs through analysis of clinical development plans, and monitoring of changes in those plans. Identifies time periods when resources will be taxed and makes plans accordingly. Outsources work regularly to ensure that in-house resources are always available for work that can only be done in-house.
Regularly reviews Department's operations and seeks to improve its effectiveness and efficiency. Develops solutions and oversees their application or directs others to this end. Participates in initiatives which seek to improve our processes. Carries out novel or complex assignments.
Plays an important role in cross-functional teams. Must be highly skilled in representing Medical Writing group in the interdepartmental planning of clinical projects, including regulatory submissions. Demonstrates exceptional ability to collaborate.
Responsible for management of medical writing resources for several development projects. Establishes and enforces timelines for multiple projects and writers. Plays a key role in negotiating timelines for primary projects throughout the organization. For projects under the Senior Manager's supervision, responsible for planning and provision of medical writing resources for submission of marketing applications. Collaborates with other departments to construct timelines and guidelines for the review of summary documents.
Reports to Director of Medical Writing and regularly informs him of the status of projects, morale and performance of direct reports, resource gaps which need to be filled, the quality and timeliness of outsourced work, status of collaboration with other departments, and any other issues which need to be addressed. Assists Director in long-term planning.
Qualifications for Job (Knowledge, Skills, Abilities, Effectiveness, Collaboration and Leadership):
Management skills. Actively increases team performance by aligning objectives, promoting a team approach, and addressing concerns or discord. Considers multiple perspectives and helps team members optimize results. Mentors Medical Writers and Editors.
Must show a broad understanding of clinical research processes, and a familiarity with regulatory processes, along with an in-depth knowledge of other clinical functional areas. Strong understanding of other clinical functions is needed to recognize and appreciate how other departments interact with, and are dependent on, Medical Writing.
Demonstrated expertise in clinical research documentation, ICH guidelines, FDA guidances, and GCP. An understanding of company SOPs, including the need for revision. Will serve as a technical expert in processes for the clinical research team. Well-developed communication and negotiation skills in team environments required.
Must have an in-depth expertise in clinical research and medical writing in particular. Acts as an authoritative resource on medical writing and other areas in clinical research. Ability to influence project strategy and document construction. Demonstrated ability to analyze and resolve complex problems.
Proficient in using Microsoft Excel, Project, and PowerPoint.
Requirements for Job (Years of Experience, Education, Certifications):
MS/MPH in Medical or Life Sciences plus 5 years' experience (or equivalent), including medical writing, project management, and/or clinical monitoring, plus at least one year of proven managerial reponsibility supervising writers.
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Contact:
Anita Zalewski
PSE Co.
215.456.9055 phone
215.565.2727 fax
anita@pse-
pse-
Contract Medical Communications Scientist Philadephia, PA area
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents).
Location: Philadelphia region
Hours: Mon - Fri; 8:30 am - 4:45 pm
Contract term: 12/22/10 (with potential for extensions)
Major Responsibilities:
• Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
• Critically assesses, interprets, and accurately summarizes medical data.
• Contributes 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.
• Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
• Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
• Interprets and monitors current and emerging communication issues and guidelines.
• Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Requirements: Degree/College Major:
• Science background (eg, MS/PhD)
• Years Work Experience Required: 3-5 years
Minimum Requirements:
• Baccalaureate degree in biomedical discipline.
• 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.
• Ability to travel nationally and internationally
Preferred Background:
• Advanced biomedical degree.
• Budget and resource management skills.
• Editor in Life Sciences (ELS) certification.
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Jobs That Crossed My Desk Through Oct. 25, 2009
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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, also has a click-by-state job bulletin (job) 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:
JD Edwards CSV Consultants
Senior Account Manager San Francisco
Medical Director San Francisco
Medical Editor/Writer NJ
Sr. Medical Director NJ
Account Executive NJ
Contract Regulatory Affairs Manager NY
Senior Manager Marketing Sciences MA
Account Manager/Sales MA
Senior CMC Manager NJ
Pharmacist NJ
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.
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See MedImmune jobs listed below at . I’ve only listed the Bay Area positions fyi. Check out other companiy listings as well.
|R&D Associate II –MedImmune Hayward, CA- 10/25/09 |
|Title: R&D Associate II Location: CA, Hayward Req: 02078 Position Summary: Major Duties and Responsibilities (including ... |
|Research Associate I/II – Santa Clara NonSales, CA 10/25/09 |
|Title: Research Associate I/II Location: CA, Santa Clara - NON SALES Req: 02076 Major Duties and Responsibilities (inclu... |
|Scientist I/II –MedImmune Hayward, CA- 10/25/09 |
|Title: Scientist I/II Location: CA, Santa Clara - NON SALES Req: 02077 Position Summary: Major Duties and Responsibiliti... |
|Clinical Data Manager – Mountain View, NonSales, CA 10/25/09 |
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|Title: Clinical Data Manager Location: CA, Mountain View - NON SALES Req: 02074 Position Summary: This position is respo... |
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|Associate Scientist II/Scientist I-MedImmune, Mountain View, NonSales, CA 10/25/09 |
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|Title: Clinical Data Manager Location: CA, Mountain View - NON SALES Req: 02074 Position Summary: This position is respo... [pic] |
|Associate Director/Senior Manager - Quality Control – Santa Clara NonSales, CA 10/25/09 |
|Title: Associate Director/Senior Manager - Quality Control Location: CA, Santa Clara - NON SALES Req: 01962 Position Sum... |
|Scientist I/II – Mountain View, NonSales, CA 10/25/09 |
|Title: Scientist I/II Location: CA, Mountain View - NON SALES Req: 01940 Position Summary: Major Duties and Responsibili... |
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My company has an opening for a Sr. R&D Engineer. We are a medical device start up based in SF. The candidate MUST have a strong background in mechanical design, SolidWorks, design control and product development experience. Please see the job posting at
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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@
1. VP Finance and Administration
This position is with a Bay Area oncology start up. They're gearing up to launch an innovative new treatment for patients with chronic myelogenous leukemia who no longer respond to traditional cancer medications like
Gleevac. This position is, literally, a ground floor opportunity. It's the #2 financial position in the company, reporting to the CFO who, along with the CEO, are based overseas. Specifically, my client seeks an experienced financial/operations executive to oversee the installation of financial, revenue accounting and cost control systems. The person hired will also have management responsibility for IT, HR, Distribution, Legal and
Facilities. The ideal candidate should have some experience working with drug distributors, developing a system for revenue recognition.
Salary range is $175-200K plus 25% bonus and lucrative options. Local candidates preferred.
VP Administration and Finance
The Vice President of Administration and Finance will provide oversight management for the U.S. financial process and all corporate administration activities including human resources, information systems, facilities and legal activities relating to U.S. operations. The position will work closely with the Senior Management Team to ensure achievement of a U.S. commercial operations buildout. The leader of finance and Administration will be expected to create business solutions and process in order to efficiently manage day to day operations at their Northern CA site. This position will be responsible for the following activities:
• Lead the U.S. financial group in all financial analysis preparation relating to revenue recognition, P&L development, and product cost development and business development analysis.
• Create financial and operational processes for the business unit including U.S. financial statement generation, general ledger management, accounts payable processing and cost accounting.
• Implement annual budgeting and quarterly rolling forecast processes.
• Manage and oversight of all operational business information technology. Lead the design and development of business information systems relating to supply- chain processes, inventory management and product distribution management.
• Enhance human resources capability in order to efficiently manage employee relations, on-boarding to separation activities, benefits management etc.
• Evaluate U.S. corporate legal needs and requirements relating to business operations and develop solutions for facilities based in Northern California.
• Additional responsibilities include oversight of facility management and corporate procurement activities.
______________________________________________________________________________________
2. Ophthalmology Account Supervisor - Orange County
This position is with a Southern CA healthcare advertising agency
specializing in medical device and pharmaceutical accounts. The ideal
candidate is someone with ophthalmic surgical equipment marketing
experience. Advertising agency experience is a real plus! Relocation
provided for qualified candidates.
Title:
Account Supervisor
Reports to:
Management Supervisor
Key Responsibilities:
Responsible for overall agency service and activities on one or more accounts.
Broad Function:
Provides daily supervision of account group personnel. Senior level client contact. Builds a strong/lasting client relationship based on progress in achieving the clients’ marketing objectives with efficiency that results in profit for the agency.
Specific Responsibilities:
Internal
• Conducts regular meetings with the account team and relevant members of other services to discuss client problems, opportunities, and work in progress.
• Determines staff hour requirements and other resources necessary to assure a high level of service to clients as well as profitability.
• Supervises, trains and motivates account team members to assure a high level of performance on behalf of clients.
• Evaluates performance and skill level of account group personnel and recommends staffing changes necessary to support client needs.
• Participates in all planning projects.
• Oversees the scheduling and flow of work from the team’s client(s).
• Reviews, periodically, each client account’s profitability with the department supervisor.
External
• Fosters a close communications relationship with client senior management, creating an atmosphere where issues regarding pricing, performance or team personnel can be discussed.
• Takes a leadership role in the development of strategic plans that will grow the clients’ business as well as generate incremental billings and income.
• Participates in major client presentations and makes other contacts that will strengthen the agency/client relationship.
• Promotes, when appropriate, other agency services such as planning or interactive.
• Insures that agency is adequately compensated for the services rendered.
_______________________________________________________________________________________
3. Account Supervisor opportunity with boutique San Francisco healthcare advertising agency, specializing in biopharma. Healthcare agency experience essential. Relocation will be provided for qualified candidates. Salary range - $100 to 140K.
Account Supervisor
RESPONSIBILITIES
Provide effective direction to client and agency team. Function as internal team leader making sure that all members of the team work together smoothly and effectively. Manage all financial aspects of the assigned products. Ensure that all project timetables are met. Interface with client at all levels of product management and with support departments. Develop, write and implement product communications plans. Continuously monitor the marketplace and provide updates to the client and agency on brand issues. Keep supervisors aware of all issues at the client and at the agency. Be aware of new products or new opportunities, which may be of interest to the agency. Key success factors specific during next 6-12 months include ability to lead agency team; ability to oversee all aspects of projects on assigned account; development of key relationships with product managers; appropriate utilization of agency resources.
Requirements
Excellent organizational skills and attention to detail. Excellent verbal and written communication skills. Ability to function as team leader. Excellent understanding of marketing principles. Excellent interpersonal skills. Basic understanding of science and drug therapy. Degree; 6-10 years pharmaceutical marketing experience; 3-5 years healthcare agency experience required; product management, market research or sales training experience preferred.
Other
Therapeutic categories to include CNS, HIV, cardiology, oncology, dermatology, pulmonology and ophthalmics.
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Paula Rutledge
President
Legacy MedSearch
(407) 898-4440
LinkedIn Company Profile
Link to Paula
FYI. If interested, contact Rick Mulligan at (407) 898-4440.
Urgent hires for 2009 start dates are indicted with the purple "HOT" icon in the postings below. We are currently scheduling interviews with the hiring manager to take place within the next 2 weeks for an immediate target hire. Qualified candidates with immediate availability are preferred and will be contacted within 24 hours. Those who have applied previously, or have recently had changes in their job search are encouraged to contact us to discuss in greater detail.
Here are our open positions for October.
Engineering / Product Development /Design
Marketing / Public Relations / Product Management
QA/RA/CA
Sales and Sales Training
"Hot Jobs" are those with an urgent need and interviews taking place within 2 weeks for an immediate target hire. Qualified candidates with immediate availability are preferred and will be contacted within 24 hours.
Medical Exp
Req?
Min.
Years
Exp.
Function
Specialty
Title
State
Min Salary
Max
Salary
w/o bonus
(est)
Minimum Education
Major/ Discipline
Experience Summary
(Not a Complete List)
____________________________________________________________________________
Min.Years Exp.10
Function Specialty - Engineering, Product Development
Senior Principal Engineer - New Product Development
(POS 169 SPE NPD)
State: IL
Max. Salary w/o bonus $90,000
Maximum Salary w/o (est): $115,000
Min. Education: Bachelors
Major/Discipline: Any Engineering discipline
Experience Summary: 10+ years of experience in Quality, Mfg or New Product Dev Knowledge of 21CFR820, ISO 13485 and ISO 14971. ASQ Certified Quality Engineer or related.
______________________________________________________________________________
Min. Years Exp: 5
Function, Specialty: Engineering, Software
Title: Principal Software Engineer
(POS 103 PSE)
State: CA
Min. Salary: $105,000
5 years
Max. Salary w/o bonus $130,000
7 year+
Min. Education: Bachelors
Major/ DisciplineAny Engineering discipline
Experience Summary: 5+ years experience in Computer Science or Engineering, C# and Multithread with Visual and strong understanding of OO design.
_______________________________________________________________________________
Min. Years Experience: 5
Function/Specialty: Engineering, Imaging
Title: Mechanical Engineer - Medical Imaging
(POS 213 ME)
Location: Midwest
Min. Salary: $68,000
Max. Salary: $75,000
Min. education: Bachelors
Major/Discipline: Mechanical Engineering
Experience Summary: B.S. in Mechanical Engineering (Minimum) 5-7 years 3D modeling design experience - Medical device experience preferred
__________________________________________________________________________________
Min. Years Experience: 5
Function/Specialty: Engineering, Imaging
Title: Electrical Engineer - Medical Imaging
(POS 213 EE)
Location: Midwest
Min. Salary: $68,000
Max. Salary w/o bonus: $75,000
Min. Education: Bachelors
Major/Discipline: Electrical Engineering
Experience Summary: B.S. in Electrical Engineering (Minimum) 5 -10 years of work experience in a design capacity. Broad knowledge of varied sub-disciplines, ranging from power to electronics.
____________________________________________________________________________
Min. Years Experience: 5
Function/ Specialty: Engineering, Product Development
Title: Product Development Engineer, New Product Development
(POS 123 PDE NPD)
State: OH/IN
Min. Salary: $68,000
Max. Salary w/o Bonus: $75,000
Min. Education: Bachelors
Major/Discipline: Any
Engineering discipline
Experience Summary: 5+ years medical device experience required, preferably in the development of knee and hip orthopedic implants and instrumentation
_____________________________________________________________________________________
Min. Years Experience: 5
Function/Specialty: Engineering, Imaging
Title: Sr. Electrical Engineer - Imaging
(POS 135 SEE)
State: MA
Min. Salary: $75,000
Max. Salary w/o Bonus: $75,000
Min. Educaton: Bachelors
Major/Discipline: Electrical Engineering
Experience Summary: 5+ years experience in an engineering environment for designing, specifying, fabricating, assembling, testing, validating, and debugging circuitry
______________________________________________________________________________________________________________________________________________________________________________
Min. Years Experience: 5
Engineering, Manufacturing
Senior Manufacturing Engineer - Medical
Biologics
(POS 202 MAN ENG)
TX
$80,000
5 years
$95,000
7 years+
Bachelors
Biomaterials, Materials Science, or Manufacturing Engineering
Manufacturing engineering experience in Antimicrobial technology, Surgical site infection biology (SSIs)
Biologics, Bio-Pharma
Spinal implants, Implant materials, Orthopedic Devices or Silver Ion
______________________________________________________________________________
Min. Years Experience: 5
Marketing, Product Management
Senior Product Manager - Medical Device
(POS 123 SPM)
Midwest
$90,000
5 years
$125,000
7-10 years
Bachelors
Sales, Marketing, Public Relations, Advertising or Related
5+ years of technical or marketing experience in medical device industry, Demonstrated knowledge of 510k submission process and heightened regulatory scrutiny
__________________________________________________________________________
Min. Years Experience: 10
Marketing, Management
VP Marketing, Medical Device
(POS 123 VPM)
Midwest
$175,000
$200,000
Bachelors
Sales, Marketing, Public Relations, Advertising or Related
A minimum of 10 years of medical device marketing is required, 3+ years at the Senior Manager, Director or VP level leading a team of 2++ direct reports
___________________________________________________________________________
Min. Years Experience: 15
Marketing Management
Director of Marketing - Patient Care (Pharma)
(POS 169 DMPC)
IL
$130,000
$135,000
Bachelors Masters+ Preferred
Business, Life Sciences, Engineering or related
Healthcare or Pharma marketing experience is required; 5 years managing teams, track record of leading a healthcare, medical device or consumer brand
____________________________________________________________________________
Min. Years Experience: 7
Marketing Public Relations
Pharmaceutical Grants
Manager, Public Relations Pharmaceutical
Grants
(POS 184 MPRPG)
CA
$125,000
$138,000
Bachelors
Sales, Marketing, Public Relations, Advertising or Related
Managed programs and developed long term grant strategy & budgets & have implemented annual grant cycles of multiple grants 30+; direct experience in pharmaceutical PR
____________________________________________________________________________
Min. Years Experience: 7
Marketing Public Relations
Pharmaceutical
Manager,
Public Relations Pharmaceutical
(POS 184 SMPA)
CA
$115,000
5 years
$138,000
7years+
Bachelors
Sales, Marketing, Public Relations, Advertising or Related
Managed total PR plans in Medical Education, Public Relations, Medical Marketing to key external audiences, primarily media representatives, healthcare providers and patients
___________________________________________________________________________
Min. Years Experience: 7
Marketing
Product Management Medical Imaging
Senior Product Manager - Medical Imaging
(POS 207 SPM)
MN
$100,000
$110,000
Bachelors
Sales, Marketing, Public Relations, Advertising or Related
7 years of product management experience in a medical device company. Must have launched 4+ products to market. Medical Imaging experience preferred.
____________________________________________________________________________
Min. Years Experience: 5
Marketing Product
Management
Orthopedics
Marketing and Project Manager, Orthopedics
(POS 209 PM)
MI
$115,000
$120,000
Bachelors
Sales, Marketing, Engineering, Life Science or Related
Marketing or Product Management experience with managing orthopedic (preferred) cranial facial, CMF, dental, neurosurgical, podiatry or similar.
________________________________________________________________________________
Min. Years Experience: 5
Marketing Management
Marketing Manager - Surgery
(POS 209 MM)
MI
$105,000
5 years
$130,000
7 years +
Bachelors
Sales, Marketing, Engineering, Life Science or Related
5 years of Marketing or Product Management experience with medical devices, focused on US market
________________________________________________________________________________
Min. Years Experience: 5
Marketing Corporate Strategy
Management
Manager Corporate Branding & e-Marketing Strategy
(POS 178 CB)
CA
$94,600
$113,800
Bachelors
Marketing, Public Relations, Communications, Advertising or related
Mastery of medical device brand, web site and marketing strategy positioning, brand architecture, naming, messaging; knowledge of new and emerging corporate branding & web site tools; PR experience
______________________________________________________________________________
Min. Years Experience: 5
Marketing
Product Management Medical Imaging
Senior Product Manager - Medical Imaging
(POS 213 SPM)
Midwest
$100,000
5 years
$125,000
7 years +
Masters
Sales, Marketing, Engineering, Life Science or Related
Minimum of 5 years experience in product development or associated fields. Strong IT background (IT related medical device products) and experience with upstream marketing
_____________________________________________________________________________
Min. Years Experience: 3
QA / RA Management
QA Engineer - Medical Device - Design Control
(POS 186 QAE)
NJ
$50,000
3 years
$75,000
5 years +
Bachelors +
RAC Certification
Scientific, technical field; advanced degree preferred.
Knowledge of regulations/standards applicable to medical implants and instruments (ISO 13485, 21CFR820, cGMPs).
___________________________________________________________________________________
Min. Years Experience: 4
Clinical Education & Sales Training
Manager, Clinical Education & Training
(POS 135 CM)
MA
$75,000
$80,000
Bachelors or RN
RN, CT or Life Sciences Preferred
Experience leading in the development of the curriculum and for delivering high quality, clinical training to internal and external customers, including physicians, radiologists and clinical staff
_______________________________________________________________________________
Min. Years Experience: 10
Sales
Regional Sales Manager Southeast
(POS 135 RSM)
East Coast
$75,000
$75,000
$200,000
at plan
Bachelors
Business, Life Science, Engineering or related
Prior Management Experience Required
10+ years demonstrated level of achievement in Surgical or Medical Capital Equipment sales with minimum of 3 years managing a sales team of at least 3. Experience selling "Off-Budget"
_______________________________________________________________________________
Min. Years Experience: 3
Sales
Orthopedic Implant Device Sales
(POS 208)
US
$75,000
$75,000
$125,000 - $150,000
Total first year comp
at plan
Bachelors
Business, Life Science, Engineering or related
3 years + Orthopedic Surgical-Implant Sales experience within the past year.
**********************************************************************************************
Debra Pohl
President, Pharmaceutical Recruitment
Alternative Resources Company
dpohl@
Debra Pohl writes…I am reaching out to you regarding a search we have begun for a Mid West (relocation provided) based, progressive pharmaceutical company creating a new role for a Director, Program Management. They are searching for an accomplished individual within the industry possessing a scientific, product development background with strong project/product management skill set and experience working with Generic (ANDA) products of multiple dosage forms. I have included a brief outline of the role (as well as a nationwide list of other roles we are working on) below for your review. Please let me know if you or someone you know may be interested in speaking about it. If not appropriate for or of interest to you PLEASE network this email amongst colleagues and friends within the industry. Networking is a powerful tool often the means by which many find their next great career move. With the current economic state and the volatility of the industry at this time everyone needs to keep an eye out for themselves as well as others.
DIRECTOR PROGRAM MANAGEMENT
Midwest location (relocation provided)
DEPARTMENT: PHARMACEUTICAL DEVELOPMENT
REPORTS TO: SR. V.P. OF RESEARCH & DEVELOPMENT
______________________________________________________________________________
POSITION PURPOSE:
This position works to condense the product development cycle by facilitating program design, cross-functional communications and focusing organizational effort on top priority programs.
PRINCIPAL ACCOUNTABILITIES:
· Manages implementation teams by developing programs including scope, schedule, budget, and risk management.
· Identifies resource conflicts and communicates departmental issues.
· Manages and facilitates the implementation of the program by maintaining program schedules, facilitating team meetings and communications.
· Manages and coordinates program control by tracking progress of each program, integrating all programs to identify constraints and provide executive updates.
· Perform other duties as assigned.
EDUCATION AND EXPERIENCE:
Ph.D preferred, MS degree in Project Management or MBA preferred
Demonstrated progression of experience in technical/scientific product development combined with full cycle project/program management experience to manage product through launch programs.
Thorough understanding of the new drug development and approval process for NDA/ANDA products. Multiple dosage form experience to include solids, liquids and ointments.
Strong management and leadership ability. Ability to mentor and lead group with vision to support company development programs.
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|Nationwide listings from ALTERNATIVE RESOURCES COMPANY | |
|JOB TITLE |STATE |
|ANALYTICAL R&D | |
|Director of Program Management |MN |
|Research Scientist/Sr. Research Scientist Analytical |NY |
|BIOANALYTICAL & PHARMACOKINETICS& DRUG METABOLISM | |
|Mgr. to Associate Director Bioanalytical & Drug Metabolism |NJ |
|DRUG SAFETY | |
|Mgr./Sr. Mgr Drug Safety Operations |CT |
|Mgr. Medical Safety |NY |
|Sr. Medical Safety Associate |NY |
|FORMULATION | |
|Director Formulation | |
|Formulation Scientist, Sr. Scientist |NY |
|MARKETING | |
|Director, Market Research |NJ |
|MEDICAL DIRECTOR | |
|Associate Medical Director - Medical Director |NJ |
|MEDICAL WRITER | |
|Senior Medical Writer |NJ |
|PROJECT MANAGEMENT | |
|Director Program Management |MN |
|QUALITY OPERATIONS (QA) | |
|Complaints Specialist |NJ |
|Senior Director of Quality-QA & QC |MN |
|QA Manager to Director |NJ |
|GCP Quality Assurance Manager/Associate Director |NY |
|GMP Quality Assurance Manager/Associate Director |NY |
|Investigations Supervisor |NJ |
|REGULATORY AFFAIRS | |
|Associate Director-Director, Regulatory Affairs |NJ |
|Senior Manager, Regulatory Affairs |CT |
|Regulatory Affairs Compliance Manager |MN |
|Regulatory Affairs Manager |NJ |
|Regulatory Affairs Project Manager |MN |
|Regulatory Affairs Associate II |NJ |
|Regulatory Affairs Associate III |NJ |
|Regulatory Affairs Associate III-Branded |NJ |
|Regulatory Affairs Associate IV |NJ |
| | |
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There have been 11 positions in Bay Area posted since October 1 on CACO Free Job Links website(). See access to full descriptions at website noted above.
Employer Position
ChemoCentryx Inc. Bioanalytical / PK Scientist
ChemoCentryx Inc. Research Associate (temporary)
Sequoia Foundation Specimen Management Specialist
Sequoia Foundation Quality Management Coordinator
Sequoia Foundation Environmental Laboratory Scientists (multiple vacancies)
Aragen Bioscience Animal Research Associate/Technician
Amgen, South San Francisco Associate Scientist, Drug Metabolism
Theravance PK/PD Modeler
Raptor Therapeutics Inc. Consultant, Bioanalytical Chemistry and Analytical Method Development
Raptor Therapeutics Inc. Consultant, Bioanalytical Chemistry and Analytical Method Development
Medivation, Inc. Associate Director/Director, Pharmacokinetics
**************************************************************************
Jon Jorgensen
Executive Search Consultant - Medical Device Division
MRINetwork
Management Recruiters of Laguna Hills
BUILDING THE HEART OF BUSINESS (TM)
Phone: 949-768-9112 x216
Email: jon@
Web:
Need an electrical engineer who has for 5+ yrs. planned and executed
projects in medical device, designing circuits, and complying with FDA
regulations for 5+ yrs. hitting deadlines and meeting the budget. Their
total career in medical device would be 10+ yrs, give or take a couple of
years, and this opportunity is with a mammoth-sized public company nearly
impervious to economic vicissitudes based in a Shangri-La type of locale
(Orange Co, So. Calif), with salary and benefits that would make anyone with
the desired background salivate.
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Get daily job alerts from Biospace—“While others search for jobs, get ahead of the competition by signing up to receive daily emails about new BioSpace positions that match your background and interests.”
Register at
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Another good reason to join Bio2Device Group is access to the jobs that are forwarded to that organization. You must attend a face-to-face meeting on a Tuesday to get the password for registration to be able to access the job listings in depth. You can also post your resume with the group for access by recruiters. See announcement for next Tuesday’s morning meeting starting at 8:30 am on Oct. 27th at Sunnyvale City Council Chambers at the website .
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Please contact me directly for more details.
Thanks,
Katy Sorenson, Ph.D.
TalentWave, Inc.
ksorenson@
Manager of Regulatory Affairs, top device company
I am searching for a Manager of Regulatory Affairs (Northern California or Dallas, TX) for my client, a successful and growing device company. This positions requires previous experience working with devices and strong Regulatory & Quality experience. Includes a competitive base salary, annual bonus, and generous benefits package.
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Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
Tel: (650) 825-2932
Fax: (650) 825-2992
Email: rkhenais@
View my LinkedIn Profile
Follow me on Twitter
I wanted to make you aware of a new contract opportunity available through our office. Interested applicants, please contact me via email or phone. Resumes to rkhenais@:
Associate Director, CV Medical Affairs is a leadership position within the Medical Affairs organization, responsible for advising for further clinical development of its marketed pharmaceutical products. Associate Director, CV Medical Affairs will work closely with internal colleagues in clinical and commecial strategies, as well as with the external investigator community. Success in this role will require the ability not only to design effective clinical strategies and the studies necessary for their fulfillment, but also the ability to communicate those strategies clearly and persuasively, and drive the appropriate publication of information reflecting study analyses and results. Associate Director of Medical Affairs will help define Phase IV strategy and execute on established strategy as finalized by the (Senior) Director, CV Medical Affairs.
This is a 6-month contract opportunity with a widely-recognized organization. More details available for qualified candidates.
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Jobs That Crossed My Desk Through Oct. 18, 2009
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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:
JD Edwards CSV Consultants
Senior Account Manager San Francisco
Medical Director San Francisco
Medical Editor/Writer NJ
Sr. Medical Director NJ
Account Supervisor NJ
Sr. Art Director NJ
Account Executive NJ
Contract Regulatory Affairs Manager NY
Senior Manager Marketing Sciences MA
Account Manager/Sales MA
Senior CMC Manager NJ
Pharmacist 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.
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Persi S. Shafto
HR Manager
680 Vaqueros Avenue
Sunnyvale, CA 94085
Tel: 408.735.6272
Fax. 408.737.8406
Main. 408.736.0224
Database Specialist, Clinical Affairs (Temporary)
Sunnyvale, CA
ArthroCare Corp. is a multi-business medical device company that develops products based on its pioneering Coblation(R) technology. The benefits of Coblation technology provide an answer to the challenges of soft tissue management in any surgical specialty where controlled and efficient ablation is of value. Current applications include: Arthroscopic Surgery, Spine Surgery, Dermatologic Surgery, Ear, Nose & Throat Surgery (ENT), and General Surgery.
Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development
Summary: Provide support to Clinical group by supporting clinical studies data management and study set-up, and managing a Clinical Library. Develop systems for organizing data in order to analyze, identify and report trends.
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)
Database-Related Activities:
• Create databases designed to allow clinical sites to collect clinical studies data
• Create and design electronic Case Report Forms (eCRFs)
• Develop database specifications based on CRFs and study protocol
• Maintain documentation and updates of database specifications
• Perform data exports for statistical analysis
• Create database built-in reports to track payments for clinical studies, patient accruals, and other activities associated with conduct of clinical trials
• Provide helpdesk services to clinical sites performing clinical studies
• Work with external consultants on database development and database updates as necessary
• Participate in testing and validation of databases created by vendors or external consultants
• Perform data management review of all clinical studies
• Perform statistical analysis on as needed basis
Clinical Studies Support Activities:
• Create and/or edit case report forms (CRFs)
• Provide feedback on feasibility of implementing proposed CRFs in an electronic environment
• Identify and implement strategies to facilitate payments made for services performed related to clinical studies participant enrollment and follow-up in clinical studies.
• Perform data entry for paper-based studies as needed
• Assist with querying and monitoring activities for individual studies
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
• Bachelor’s degree, or equivalent, required; (Biology/Science major a plus). Clinical research experience in the medical device Industry highly desired.
• Proficiency in SQL programming is preferred
• At least 5+ years of experience working in the medical device industry.
• Excellent communication skills required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.
For consideration of this and other opportunities please visit our career center at:
Equal Opportunity Employer
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Please contact Mary Campion (x10) or Matt Takahashi (x12) at 310-378-1217 or mary@.
We are engaged with a rapidly growing company who is a leading developer of cell biology systems for the laboratory research, biotech and pharmaceutical markets. They have launched a new benchtop platform and are looking for a Product Marketing Manager for their consumables business based in Southern California.
The incumbent will manage all aspects of marketing programs for specified products. Design, develop, and execute marketing strategies, pricing strategies and direct advertising and promotional activities. Responsibilities may also include research and evaluation of new products. S/he will identify, manage and deliver product development guidance, customer and market requirements and product specifications. Monitor and prepare competitive analysis and provide marketing support, including marketing analysis, planning and project management including budget control.
They are ideally looking for a professional with three to five years of experience in a similar product management or marketing role. Sales and/or business development experience is a plus. Strong communication, analytical, financial modeling, project management and planning skills necessary. Business development and cross-functional team leadership experience preferred. Proven ability to identify new business opportunities, set and meet aggressive objectives and develop strong working relationships also preferred.
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If you or someone you know has experience and qualifiactions please contact me at: narogbryant@.
Blair Narog
Im looking for a Clinical Drug Supply Consultant with expertise in tracking global supply distribution, IWRS, spreadsheet analysis and planinng for multiple products.
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If you, or someone you know, has the skills and background, please contact me at: pravin@.
Pravin Soni
My client is looking for a consultant who has expertise in the area of microbiology related issues associated with device design and manufacturing: reducing bioburden, testing for bioburden, contamination control, microbial challenge testing.
************************************************************************************************* Here's a spot people can directly apply instead of sending resumes:
The company I work for is currently in the process of finding candidates for a Mechanical Engineer II position located in Hercules, CA. Specifically we're looking for someone with high volume plastic part design experience in the life science industry, and knowledge of Solidworks/FEA.
Location(s): Hercules CA
Career Field: Engineering
Education: BS in Mechanical Engineering
Skills and Experience:
Education: B.S. in Mechanical Engineering
Experience: 4+ years experience in product design and development with consumer lab equipment and consumables. Plastic injection mold part design experience preferred. Sheet metal design and familiar with machining processes and coatings.
Skills: Solidworks 3D modeling and drawing creation, FEA a plus. Knowledge of BOM structures. Effective communicator.
Duties and Responsibilities:
Product design and development as it relates to the Life Science industry. Using solid modeling, design and refine mechanical components, create prototypes and work with suppliers to make a finished product. Work in a team environment with the ability to communicate across professional disciplines. Ability to travel up to 15 percent internationally (project dependent). Ability to see the design through to completion. Perform design reviews. Ability to create verification test plans, execute them and report on results. Build and support overseas supplier relationships. Be able to manage multiple projects/assignments. Work independently with little of no supervision.
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PROJECT MANAGER/SENIOR PROJECT MANAGER
Posted by: "NancyS" njs@
Wed Oct 14, 2009 5:54 pm (PDT)
Our client, located in the East Bay, is a small IPO focusing on the development of small molecule pharmaceuticals for treating metabolic disorders, cardiovascular disease, inflammation and oncology. They are currently seeking a Project Manager/Senior Project Manager who will oversee and coordinate development projects from discovery through IND filing and early development.
Thank you so much for taking the time to review the following job description. If you (or someone you know) has the skill sets we are looking for, please send the CV to njs@ for consideration. If you have any questions, please don't hesitate to call me. I look forward to hearing from you or your referrals.
NJS Recruiting Services is a search firm specializing exclusively in Biotech and Pharmaceutical searches in various areas of drug development. We have been in business since 1994 and are located in the Bay Area of California. We work primarily with companies also in the Bay Area. This enables us to develop closer, professional relationships as we visit with our clients regularly at their location.
In order to better serve you, please feel free to send us an updated version of your CV for our database.
Nancy J. Symonds
President
NJS Recruiting Services
415-491-1541
njs@
Project Manager/Senior Project Manager
Responsibilities
•Develop budgets, timelines, and set milestones for each development program, with appropriate functional input
•Ensure budgets, timelines, milestones and quality expectations are met.
•Pro-actively identify issues that may delay product development and recommend appropriate action to be taken.
•Ensure accurate and timely communications with project teams and management of any issues impacting budgets, timelines or milestones
•Act as key interface with scientists to ensure smooth transition of projects from discovery to development.
•Deliver to regulatory documents and reports, as required
•Lead project team meetings.
•Present development data and plans for internal and external forums, as requested.
Position Requirements & Experience
•Bachelors degree; biology or chemistry discipline preferred; Ph.D. or advanced degree highly desirable; MBA desirable
•At least 5 years of relevant drug development experience, small moecule experience preferred.
•Previous project management experience in biotech company, with lead or co-lead responsibility for at least one successful IND.
•Ability to multi-task while working within a fast paced and dynamic environment.
•Detail and team oriented with excellent cross-functional team leadership and participation skills.
•High energy with strong organizational skills.
•Highly self motivated a definite plus
•Strong interpersonal skills
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Contact:
Jan Clements
janclements@
818.552.2105 (direct line)
928.585.2036 (e-fax)
Med Exec International / RxResearch Staffing
Contract Medical Writer Needed for Urgent
Clinical Study Report Project
A leading biotech company has an immediate need for an experienced Clinical Writer to work on site for 3 months. Will be writing the final Study Report.
Location: Santa Clara, CA; MUST work on site for duration of the 3-month contract; currently live in the Santa Clara commutable area (no relocation or travel expenses)
Length of Position: 3 months for 40 hours/week, or as close as possible
Requirements:
• Strong experience writing final Clinical Study Reports
• Cardiology experience required
• Medical Device experience
• Narrative writing/review
• Analyses of data
• Be a team-worker
• Be able to work with short timelines
Thanks for considering this job description, and please forward this letter to others who you think may be interested and qualified.
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We need an Operations Project Mgr. for one of our best clients in the Southeast. If you know of anyone that may be interested please pass along our information.
Thank you for your time.
Sincerely,
Nancy Cody
Director of Staffing
Wirth & Associates
wirth@wirth-
OPERATIONS PROJECT MANAGER
Department: Operations
Reports to: Director, Supply Chain Management
85 – 100K annually, relocation assistance, all applicable benefits and bonus program eligibility.
Overall Responsibilities
¨ Manage all domestic and international (Europe and Asia) product launches and the multiple tasks involved.
¨ Lead and/or provide support for internal and external projects such as but not limited to new equipment qualifications, alternate material qualifications and commercial product launches.
¨ Assist in the preparation and review of functional protocols, reports and SOPs.
¨ Interface as a liaison between Operations and all internal departments relative to new non commercial/commercial projects/products.
¨ Promote, develop and nurture project teams so as to facilitate, manage and direct special projects both internally as well as with business partners and vendors.
¨ Representative for Operations (Engineering, Manufacturing, Purchasing and Supply Chain) in Portfolio teams where a product is being prepared for commercialization.
¨ Lead project teams and functions as primary advocate of project where assigned.
_________________________________________________
SENIOR PACKAGING OPERATIONS MANAGER - -087-J1010109C
Location: Northeast
Salary: $120,000
Will oversee a 14-line packaging operation for a rapidly-growing private label manufacturer of solid dose products. This will encompass bottling, imprinting, blister packs, inspection and cartoning and a workforce of 700 people. Qualified candidates will have a demonstrated track record of success managing OTC or prescription drug packaging to include a strong knowledge of FDA/GMP requirements, a BS degree minimum and an ability to work in a fast-paced environment where additional responsibilities and growth are imminent.
________________________________________________
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.
_____________________________________
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 001F-08309P
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.
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Contact:
Jana Melamut
Senior Recruitment Consultant
Tel: 813 854 2091
Email: Jana.Melamut@
Web:
Medical Writer, Contract – Palo Alto, CA
Status: Contract, 14 months
Location: On site, Palo Alto, CA
Pay Range: Will discuss with each candidate
Brief Job Description and Required Skills:
• At least 3 years' experience, preferably more, of writing CSRs and summaries, 8-10 years as a writer
• Science degree, preferably MS or PhD
• Can work on-site at Palo Alto 100%, ie, lives in SF Bay Area
• Experience with NDA filing
• Experience preferred in anemia, renal failure, or therapy with related issues such as oncology, hematology
Requirements:
• BS/BA - MD/PhD preferred, but not required
• Request for samples: not at this time
• ********************************************************************
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Joan Blitman
Vice President
Jack Ferrell & Associates
Email: joan@
Phone: 609-448-2490
Medical Editor – Bridgewater, NJ
Our client, a strategic medical communications agency located in Bridgewater NJ needs a highly qualified Medical Editor to provide high-quality editorial services for a wide range of projects, as part of medical communications programs in different therapeutic areas, for different clients, addressing different target audiences, This Medical Editor will manage the editorial process to ensure the highest standard of messaging, language, and style. This is a full-time staff position with excellent benefits.
Responsibilities:
• Review and revise projects for accuracy, clarity, conciseness, organization, and word choice
• Review and revise projects for consistency, style, and grammar
• Perform copyediting of all content
• Review articles for adherence to style guidelines (AMA and other) and suggest revisions
• Review incorporated comments/revisions throughout development and on final manuscripts
• Ensure that medical content is accurate and supported by reviewing all content against reference material
• Interact closely on numerous teams throughout the development and review process
• Monitor project progress and hours expended within team (timelines/budgets)
• Utilize RefMan in the development process
• Initiate, track, and process appropriate copyright permissions
Requirements:
• Ability to understand client objectives in relation to messaging
• Understand medical content development process
• Demonstrate high level of editing skills
• Excellent teamwork and interpersonal skills
• Ownership and commitment to overall product quality
• Excellent time management and ability to handle reprioritization
• Degree in English and/or equivalent experience
• At least 5 years of experience as an editor in a medical communications agency
• Strength in all Office tools (Word, Powerpoint, Excel, and Internet)
************************************************************************************************* Contact:
Joan Blitman
Vice President
Jack Ferrell & Associates
Email: joan@
Phone: 609-448-2490
Program Director – Bridgewater, NJ
Our client is a strategic medical communications agency located in Bridgewater NJ. We require a highly qualified Program Director to lead the Strategic Publications Plan (SPP) team to ensure the development and delivery of high quality innovative programs and projects.
Responsibilities:
• Lead the SPP team in a timely, targeted and on budget manner
• Maintain profitability and productivity of the team, meeting financial targets and growth of accounts and clients
• Create and implement innovative, targeted products and services
• Partner with Business Development to win new business
• Develop and maintain strategic contact with customers at both execution and senior level
• Manage the strategic and tactical operations to ensure short and long term success of the communication strategies for the account
• Maintain relevant scientific knowledge of the therapeutic areas and compounds for which communication strategies and plans are being developed
Requirements:
• Advanced Life Sciences Degree (MD, PhD, or PharmD)
• Thorough understanding of the full range of medical communications outputs
• Knowledge and understanding of the current pharmaceutical and biotech industries to include drug development process, healthcare, medical education, publications, and agency environment from both an international and domestic perspective with at least 5-8 years of experience working in these areas
• Broad therapy area expertise
• Sound working knowledge of ethical, compliance, legal and regulatory guidelines and requirements related to medical communications, working knowledge of the commercialization process
• Extensive knowledge of SPP and developing medical marketing strategies and tactics
• Experience in publication management and knowledge of publication guidelines
• Certified Medical Publications Professional (or eligible)
• Member of ISMPP, AMWA
*************************************************************************************************My employer, SuperGen, has posted a new position on its website for Senior Medical Writer:
At our Salt Lake City facility, these positions are currently open:
Director or Sr. Director Medicinal Chemistry
Head of Discovery
Research Scientist, Assay Biology
Research Scientist, Translational Pharmacology
Full list of openings at , click on Join Us.
|Title / Description |Company |Location |Date Posted |
|Manufacturing Engineer, PCA |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Primary Function of Position: Manufacturing | | |View full description |
|Engineer is responsible for supporting production | | | |
|released robotic s... | | |Save to MyBeakerBoard |
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|Manufacturing Engineer, Electrical |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Primary Function of Position: The successful | | |View full description |
|candidate will: · Apply his/her | | | |
|manufacturing and ele... | | |Save to MyBeakerBoard |
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|Sr. Manager, Instrument Development Engineering |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Primary Function of Position: The Instrument | | |View full description |
|Engineering Manager is responsible for guiding the | | | |
|development, docum... | | |Save to MyBeakerBoard |
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|Sales Training Manager |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Training · Creation of agenda, curricula | | |View full description |
|and training materials for all Clinical and Sales | | | |
|Training at I... | | |Save to MyBeakerBoard |
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|Assistant Video Editor |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Position Description · The Assistant | | |View full description |
|Video Editor will work under the direction of the | | | |
|Video Productio... | | |Save to MyBeakerBoard |
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|Document Control Specialist |Intuitive Surgical |Sunnyvale, CA US |09/28/2009 |
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|Primary Function of Position: The Document | | |View full description |
|Control Specialist will be responsible for handling| | | |
|multiple tasks an... | | |Save to MyBeakerBoard |
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See details at
|Title / Description |Company |Location |Date Posted |
|Technical Sales Specialist |Prometheus Laboratories |, US |10/12/2009 |
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|For further information about our current Technical| | |View full description |
|Sales Specialist openings, click on "Apply Now" and| | | |
|you will be dire... | | |Save to MyBeakerBoard |
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|Sr. Technical Operations Scientist II |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|SUMMARY Responsible for developing and | | |View full description |
|troubleshooting assays and procedures to transfer | | | |
|to Lab Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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|Sr. Technical Operations Scientist II |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|SUMMARY Responsible for developing and | | |View full description |
|troubleshooting assays and procedures to transfer | | | |
|to Lab Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Sr. Technical Operations Scientist II |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|SUMMARY Responsible for developing and | | |View full description |
|troubleshooting assays and procedures to transfer | | | |
|to Lab Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Sr. Manager, Clinical Operations |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|SUMMARY Position responsible for implementation, | | |View full description |
|management and coordination of diagnostic and | | | |
|therapeutic clinical stud... | | |Save to MyBeakerBoard |
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|Product Manager |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|Summary: Management, design, and production of | | |View full description |
|planned marketing programs of the Prometheus Celiac| | | |
|testing including Cel... | | |Save to MyBeakerBoard |
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|Medical Accounts Representative II |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
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|SUMMARY Telephonically and electronically | | |View full description |
|Interfaces with internal and external parties to | | | |
|collect payment on Prometheus... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Medical Accounts Representative II |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
| | | | |
|SUMMARY Telephonically and electronically | | |View full description |
|Interfaces with internal and external parties to | | | |
|collect payment on Prometheus... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Manager, Sales Training |Prometheus Laboratories |San Diego, CA US |10/12/2009 |
| | | | |
|** This position is open to Prometheus employees | | |View full description |
|only.** Travel requirement is 10-15%. SUMMARY | | | |
|Responsible for managing ... | | |Save to MyBeakerBoard |
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|Diagnostic Quality Analyst I |Prometheus Laboratories |, US |10/12/2009 |
| | | | |
|SUMMARY Performs quality control related activities| | |View full description |
|supporting clinical laboratory testing. ESSENTIAL | | | |
|DUTIES AND RESPONS... | | |Save to MyBeakerBoard |
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|Clinical Research Associate II |Prometheus Laboratories |San Diego, CA |10/12/2009 |
| | |US | |
|SUMMARY Responsible for coordinating | | |View full description |
|activities of Rx and Dx clinical trials and | | | |
|sample collection for diagnostic test d... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Analyst/Sr Analyst Sales Ops |Prometheus Laboratories |San Diego, CA |10/12/2009 |
| | |US | |
|SUMMARY Responsible for managing the | | |View full description |
|tactical implementation of Sales Force | | | |
|Incentive Compensation plans, sales force | | |Save to MyBeakerBoard |
|re... | | | |
| | | |Email to a friend |
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Interested applicants please apply directly at: Search Job ID: 35551
Questions: Contact Stephanie Kemp at skemp@stanford.edu
Employment Opportunity: Stroke Center Research Assistant position
Location: School of Medicine- Stanford
Category-Research; Salary 2P1
Dated Posted: Aug. 27, 2009
The Stanford Stroke Center seeks a 100% FTE Social Science Research Assistant to assist in the conduct and coordination of clinical research projects. Duties include: prepare initial study proposals for submission to the IRB and study sponsors, including informed consent documents and budget proposals. Coordinate study renewals by the IRB and sponsors. Prepare and monitor study budgets. Assist in tracking study revenues and expenditures. Be responsible for compliance documentation and communication between collaborating institutions, prepare annual progress and financial reports, and assist with other grant or research-related administrative work. Complete all aspects of protocols, and accurate completion of all study report forms. Screen and interview patients for eligibility as subjects for research protocols. Assist in obtaining informed consent from patients and families. Maintain all study documentation including copies of pertinent medical records. Collect and record study data. Maintain complete data files on all study patients. Compile and monitor databases to be used as resource for current and future studies. Coordinate data review by FDA/study sponsors. Attend study related lectures, rounds, and other educational activities. Interact with research personnel, patients, families, other health care personnel, pharmaceutical representatives and sponsors to enhance data collection and patient adherence to protocols. Function as an advocate for study patients and their families. Manage the regulatory files for all assigned protocols to ensure compliance with federal and pharmaceutical Sponsors’ guidelines.
QUALIFICATIONS: At least two years of demonstrated experience in the conduct and coordination of clinical research. The candidate must be familiar with medical terminology, patient enrollment in clinical research trials, and data abstraction from medical records. The candidate must have good excellent computer skills including database management, Word, Excel and computer and/or web-based data entry. The candidate must be a self-starter and independent problem solver who can accomplish goals with minimal supervision, and demonstrate an ability to set priorities and coordinate multiple assignments. The position requires superior follow-up skills and ability to interact effectively with a wide variety of people; excellent telephone skills; ability to work independently; accounting skills a plus; BS degree required.
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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.
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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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.
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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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