Associate Director, Medical Writing

Role: Medical Writer supporting clinical development and regulatory submissions for Corcept's therapeutics in cortisol modulation, including treatments for hypercortisolism and oncology. Responsibilities: authoring and editing clinical/regulatory documents such as NDAs, protocols, CSRs, and Investigator’s Brochures; collaborating with cross-functional teams (Biometrics, Clinical Ops, CMC, Regulatory Affairs); managing timelines, leading comment resolution, overseeing vendors, and developing medical writing processes. Requirements: BA/BS in a scientific field; 7+ years of regulatory medical writing experience in pharma, with expertise in clinical study protocols, reports, and submission content; strong understanding of drug development, regulatory guidelines (US and EU), and electronic document management tools. Preferred: advanced degree (PhD, PharmD, MS); experience across multiple therapeutic areas including oncology or hypercortisolism; familiarity with e-CTD. High-Value: focus on cortisol-related diseases, experience with complex clinical/regulatory documents, and working in a fast-paced biotech environment. WorkSetup: headquarters-based in Redwood City, CA, with US work authorization required.