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Inside the Insider |
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Open Jobs and Contract Opportunities
Senior Manager, Medical Writing; San Francisco Bay Area |
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Jobs and Contract Opportunities |
 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
(title flexible for junior candidate) San Francisco Bay Area |
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This is a permanent, on-site position in the San Francisco Bay Area. An unpaid writing test is REQUIRED as the first step in the interview process.
Description
- Will provide support to Clinical Development and Regulatory Affairs
- Will analyze/interpret clinical study data for scientific conclusions
- Will create medical/scientific documents to support clinical development documents such as protocols, IBs, and CSRs
- Will be responsible for preparation of scientific abstracts/posters/slides\ presentations/manuscripts
- Will assist with generation of regulatory submission documents such as eCTD/NDA clinical summaries, IND applications and briefing books
- Will lead document review/comment resolution meetings with cross-functional teams
- Will perform literature-based research for writing activities
Requirements
- Bachelor degree REQUIRED, advanced degree preferred
- 5+ years in biotech/pharma specifically supporting clinical/regulatory groups
- Solid experience in protocols, IBs, CSRs, work on an eCTD/NDA submission a PLUS
- Data analysis experience
- Infectious disease/understanding of microbiology a PLUS
- Okay with rolling up the sleeves and getting in the trenches
- Superior MS Office skills
- Travel ~2 weeks/year
Contact
Interested candidates please email Lindsey Summers at lsummers@pharmascent.com, or call at 303-694-5482.
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