Manager, Medical Writing Operations

Role: Manager of Medical Writing Operations, focused on leading document support across regulatory, clinical, and safety domains within a biopharma setting. Primary objectives include optimizing document creation processes, ensuring regulatory compliance, and supporting submission readiness for rare disease therapies. Responsibilities encompass serving as a subject matter expert in Microsoft Word formatting, developing and maintaining document templates and style guides, managing document timelines, and authoring/coordinating clinical and regulatory documents such as protocols, CSRs, IBs, and CTD components. The role involves collaboration with cross-functional teams including Regulatory, Clinical Development, Biometrics, and Pharmacovigilance, and requires ensuring documents meet FDA, EMA, ICH standards and are scientifically accurate. Qualifications include a Bachelor's degree in Life Sciences or related field, 6+ years in medical/regulatory writing or document management within biotech/pharma industries, with advanced proficiency in Word, document publishing, and regulatory workflows. Preferred skills include experience with authoring/review tools and electronic document management systems like Veeva Vault. The position demands strong project management, attention to detail, and the ability to adapt within a fast-paced, dynamic environment. International travel up to 10% may be required. The role is based in San Diego but offers remote work options.