26 November 2010                 Published weekly by Biotech Ink, LLCVol 3 No 30

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Inside the Insider

Principal Medical Writer, Biogen Idec; Cambridge, MA

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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. 

Because of the tough job market, the Insider now lists open jobs 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 [email protected]. We'd be delighted to publish such positions in the next issue of the Insider.
aPrincipal Medical Writer
Biogen Idec; Cambridge, MA

This position is an in-house medical writer position that sits in Cambridge, MA (specifically Kendall Sq). It has the ability to telecommute up to 40%, but that is the maximum. Relocation benefits are available for out-of-state candidates.

Job Description


Prepares clinical regulatory documents (protocols, CSRs, IBs, clinical summary documents); coordinates preparation of clinical documents for regulatory submissions for one or more programs. Represents Medical Writing department on project teams; leads document-related meetings. Reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area. Mentors junior writers on departmental processes related to document preparation; reviews documents written by junior writers for content and format; coordinates work of multiple writers contributing to a regulatory submission. Participates on departmental and interdepartmental initiatives. Able to analyze data. Has strong communication, organizational, and meeting skills.

Qualifications

7+ yrs regulatory writing experience with Master's; 6+ yrs regulatory writing experience with PhD.

Education


Degree in life or health science discipline. Master's required; PhD preferred.

Contact

If you're interested, please send your resume and questions to Matt Soloperto at [email protected].
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Comments or questions? Email Susan at [email protected].