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Senior Medical Writing Director - Regulatory Submissions

Socket

Corcept Therapeutics, headquartered in Redwood City, CA, seeks a medical writing professional to support regulatory submissions and ensure alignment with US and ex-US requirements. You will author, edit, and format NDAs, protocols, CSRs, and IBs, collaborating with cross-functional teams to gather input and maintain timelines. The role demands strong writing, attention to detail, and experience across therapeutic areas, with a track record in regulatory documents and familiarity with e-CTD #J-18808-Ljbffr Socket

Vacancy posted 3 days ago
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