4 May 2012                        Published by Biotech Ink, LLCVol 5 No 2

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Inside the Insider

Open Jobs and Contract Opportunities

 
Manager to Associate Director, Medical Writing (Multiple Positions);
San Francisco Bay Area

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Jobs and Contract Opportunities
 
Susan E Caldwell, PhDThe 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.

Manager to Associate Director, Regulatory Medical Writing (Multiple Positions)

San Francisco Bay Area


San Francisco Bay Area (MUST be on-site, no flexibility for remote work)

Permanent (relocation candidates okay)

 

Responsibilities

 

Proven experience writing regulatory documents including CSRs, CTD Summaries, Investigative Brochures ect

 

Ability to lead in depth Medical Writing projects while concurrently managing the work of other medical writers

 

Regulatory writing SME for project teams; main point of contact for cross-functional groups

 

Works cross-functionally with contributors such as Clinical Operations and Biometrics Departments to ensure accuracy of data, while adhering to project timelines

 

Qualifications

 

Bachelor degree REQUIRED, advanced degree highly preferred

 

Significant experience within Regulatory Affairs Medical writing in Pharma/Biotech

 

Minimum of 5 years of medical writing of documents for regulatory submissions

 

Contact


Please email Lindsey Summers at lsummers(at)pharmascent.com or call at 303-694-5482.

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Comments or questions? Email Susan at caldwell@biotechink.com.