Department: Clinical
Job Title: Director of Medical Writing
Job Location: Seattle, WA
Requisition #: 2008B4NB
Description:
This position will be responsible for directing and coordinating global reporting and summarizing clinical trial results and for preparing clinical protocols. Will represent the Clinical Development in global regulatory filing process management through both pre- and post marketing periods. Will provide global medical writing support to Business Development and Marketing. This includes working closely with project team members to ensure that protocols, clinical trial reports, Investigator Brochures, IND reports, NDA, sNDA, and orphan drug applications, post-marketing reports, and international regulatory filings are accurate and prepared in accordance with the appropriate regulations and guidelines as well as managing internal and external medical writing personnel.
Job Requirements:
Requires a Bachelor’s degree (advanced degree highly preferred) in a scientific or medical discipline, plus a minimum of 8 years related experience in clinical research and medical writing. Prior management and knowledge of FDA, European, and ICH drug development regulations and guidelines also required.
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