| 26 October 2012 Published by Biotech Ink, LLC | Vol 5 No 5 |
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Inside This Issue of the Insider
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Open Jobs and Contract Opportunities
Senior Medical Writer; Greater Boston Area, MA
Manager/Senior Manager, Medical Writing; San Francisco Bay Area, CA
Regulatory Writer; San Francisco Bay Area, CA
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Jobs and Contract Opportunities
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 The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
The Insider lists job and contract opportunities worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles. If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider.
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Senior Medical Writer
Greater Boston Area, MA | |
Permanent position in Greater Boston Area, MA
Responsibilities
- Independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data
- Documents include clinical study reports, study protocols, investigator's brochures, and manuscripts
- Conducts overall planning of the clinical sections of global submissions
- Works with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy
- Advises management regarding project resource requirements, and manages project-related activities of resources assigned
- Reviews statistical analysis plans and case report forms, as required
- Performs QC review of clinical study reports and other submissions written by other medical writers
- Keeps management informed on progress documents and other project related information, assist management in projecting resources, and perform administrative duties
- Works independently with the sponsor representatives with regard to document planning, review, revision, and finalization
- Documents to be completed within a time period that supports project needs and deadlines
- Documents to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers
- Documents must meet ICH guidelines and company document standards
Requirements
- Bachelor degree REQUIRED
- 5+ years of pharmaceuticals, biotech, or CRO regulatory medical writing experience to include protocols, CSRs, narratives, and updates to IBs
- At least 1 of these REQUIRED (NDA submission documents, specifically ISS, ISE, clinical summaries)
- Experience with UPDATES to DSURs and IND submissions a PLUS
- Working knowledge of ICH and other regulatory guidelines required
- Ability to accurately and clearly present clinical data, strong verbal, written, and interpersonal communication skills, and proficiency in Word
- Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred
- Excellent regulatory writing skills, and a keen attention to detail also are required
Contact
If interested, please email Lindsey Summers with your resume at lsummers@pharmascent.com. For questions, please call Lindsey at 303-694-5482.
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Manager/Senior Maanger, Medical Writing
San Francisco Bay Area, CA | |
Permanent position in the San Francisco Bay Area.
Responsibilities
- Prepares regulatory documents such as clinical study reports and Investigator Brochures in-line with regulatory requirements and company standards
- May work in tandem with a more senior writer on other documents types
- Medical writing activities at the level of single study reports and noncritical documents are performed alone
- Involved in the preparation of more regulatory documents (for example, CTD summaries, regulatory responses) with direction from local or group management
- Contributes to other non-regulatory medical writing activities as required
- May lead document timeline/resource planning within the submission team
- Works collaboratively with functional contributors ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines
- Coordinates the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions
- Contributes to development work in relation to document standards, continuing MS template development, and other aspects of document management.
- Excellent verbal communication skills.
- Knowledgeable of regulatory document requirements/guidelines.
- Well developed computer skills including proficiency in Word, Adobe and Excel
Requirements
- BS degree and minimum 5 years of relevant experience within clinical R&D or regulatory affairs, such as pharmaceuticals/biotechnology, which includes 3 years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions
- 5+ years of experience with a BA degree. 4+ years of experience with an MS degree. 2+ years of experience with PhD, MD or DVM
- 3+ years in medical writing or the clinical submissions environment preparing documents for regulatory submissions.
Contact
If interested, please email Lindsey Summers with your resume at lsummers@pharmascent.com. For questions, please call Lindsey at 303-694-5482.
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Regulatory Writer
San Francisco Bay Area, CA | |
On-site medical writing position in the San Francisco Bay Area.
Contact
For more details on this opportunity, please email Jane Pondel at jane.pondel@randstadusa.com, or call 847-527-6118.
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