Manager, Medical Writing Operations

Role: Manager of Medical Writing Operations supporting regulatory, clinical, and safety documentation for a biopharma focused on rare diseases. Main objectives include leading document support processes, managing formatting, templates, and document quality standards, and ensuring submission-ready deliverables. Responsibilities involve advanced document formatting expertise, managing timelines and review cycles, developing and maintaining templates and style guides, and collaborating with cross-functional teams (Regulatory, Clinical, Biometrics, PV) to ensure regulatory compliance and document accuracy. Qualifications: Bachelor's in Life Sciences or related field; 6+ years in medical/regulatory writing, document management, or publishing within biotech, pharma, or CRO environments; proficiency in Microsoft Word, document production, and regulatory requirements (FDA, EMA, ICH). Preferred skills include experience with authoring/review tools, electronic document management systems (Veeva Vault), and publishing tools. High-value specifics include support for regulatory submissions in drug development, with a focus on rare disease programs, across all phases of development. The role involves up to 10% domestic and international travel, with an onsite requirement in San Diego, and offers a comprehensive benefits package and competitive salary range ($116K–$151K).