Job Summary: We are currently seeking a Associate Director, Medical Writing for our Edison, New Jersey location. This position is responsible for the preparation of protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), clinical sections of the CTD (2.5, 2.7.3, 2.7.4), integrated summaries of efficacy and safety (ISE and ISS), briefing books, and regulatory responses. The position will be responsible for hands-on writing as well as supervision of work performed by CRO/consultant ...
Daiichi Sankyo, Inc. - 30+ days ago
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