Associate Director, Medical & Regulatory Writing

Role: Associate Director, Medical & Regulatory Writing at Xencor, leading the development of clinical and regulatory documents for biopharma therapeutics. Responsibilities: authoring and reviewing clinical protocols, Investigator’s Brochures, Clinical Study Reports, and regulatory submission documents; developing templates and style guides; coordinating external vendors; providing guidance to junior writers and ensuring document quality, consistency, and compliance with regulatory standards. Requirements: Bachelor's degree in life sciences or writing; 10+ years in medical/regulatory writing within biotech/pharma; experience leading regulatory submissions (INDs, CTAs, NDAs, BLAs) and oversight of writing teams; strong understanding of drug development and clinical data presentation; proficient with tools like SharePoint and Veeva RIM. Preferred: advanced degrees (Master’s/PhD), small company experience, AI tool familiarity. HighValue: expertise in clinical documents, regulatory filings, cross-functional collaboration, leadership in regulated environments. WorkSetup: hybrid San Diego; occasional travel between Pasadena and San Diego offices.