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Inside This Issue of the Insider
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Open Jobs and Contract Opportunities
Senior Manager, Medical Writing; Foster City, 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 Manager, Medical Writing
Foster City, CA |
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Location: San Francisco Bay Area
The Medical Writing function resides organizationally within within Regulatory Affairs, and provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions across antiviral, respiratory, cardiovascular, and oncology indications. This position is responsible for working with project teams across sites to produce complex clinical documents for global regulatory submissions, including clinical summaries and overviews, clinical study reports (CSRs), investigator brochures, pediatric investigational plans (PIPs), clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents.
- Is able to prepare a wide variety of regulatory documents independently or with minimal supervision
- Writes multi-study summary documents for pivotal studies
- Writes sections of product approval applications and other submissions
- Works with Biometrics on clinical data interpretation
- Reviews and prepares FDA briefing packages
- Serves as a cross-functional resource
- Can facilitate issue resolution and lead multi-functional teams with clear direction through complex processes
Essential Duties and Job Functions
Demonstrated ability to prepare a wide range of regulatory documents, such as clinical study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans [PIPs], and regulatory responses, in-line with regulatory requirements and internal document standards, and without appreciable supervision
- Contributes to other non-regulatory medical writing activities as required.
- Participates in submission teams and provides advice/guidance for optimal presentation of data for achievement of document objectives.
- Leads document timeline/resource planning for assigned projects within the submission team.
- Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines.
- Performance management may be required.
- Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions.
- Leads/contributes to development work in relation to document standards, continuing MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing.
- Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level.
- Excellent verbal communication skills.
- Knowledgeable of regulatory document requirements/guidelines.
- Well developed computer skills including proficiency in Word, Adobe and Excel
Knowledge, Experience, and Skills
- Typically requires a BS degree and minimum 10 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology which includes 5+ years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.
- 10+ years of experience with a BA degree.
- 8+ years of experience with an MS degree.
- 4+ years of experience with PhD, MD or DVM.
- 5+ years in medical writing or the clinical submissions environment preparing documents for regulatory submissions.
Contact
If interested, please email Jennifer Holt at Jennifer.Holt@gilead.com.
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