17 June 2011                    Published weekly by Biotech Ink, LLCVol 4 No 13

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Inside the Insider

Open Jobs and Contract Opportunities
 
Director, Regulatory Writing; Rockville/Gaithersburg, MD
Medical Writing Publications Manager; Location Unspecified

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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.

Director, Regulatory Writing

Rockville/Gaithersburg, MD


Requirements
 

8+ years experience writing clinical regulatory documents including clinical study reports


Previous Experience writing, reviewing, and/or managing summary and/or overview sections of one or more licensing applications


3+ years direct supervisory experience for multiple direct reports or contract writers within a medical writing group


Experience reviewing performance and giving performance evaluations, including setting performance goals and managing issues


Experience in hiring, training, leading, coaching and mentoring medical writing staff


Background in biologics a plus


Contact
 


Cathy Inkeles

Clintel Services, Inc.

301-987-0442

cinkeles@clintelservices.com

Medical Writing Publications Manager

Location Unspecified


Requirements  

 

5+ years writing/editing publication experience in pharma industry, communications agency or academic setting  

 

Lead Author of 8+ clinical/scientific publications or formal medical writing acknowledgement in 8+ clinical publications   

 

Previous experience with management of publication-related vendors required; supervisory experience for direct reports a plus  

 

MS degree in a biomedical discipline required; doctorate level (PharmD, MD or PhD) preferred  

 

AMWA, BELS, and/or ISMPP certification a plus

 

Contact 

 

Cathy Inkeles   

Clintel Services, Inc.   

301-987-0442   

cinkeles@clintelservices.com   

 

 

 

 

 

 

 

 

 

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