Senior Manager, Medical Writing

Role: Senior Manager of Medical Writing responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents supporting drug development and regulatory submissions. Responsibilities include collaborating cross-functionally to produce high-quality, compliant documents (protocols, CSRs, IBs, CTD sections), managing timelines, analyzing complex data, and advancing medical writing standards. Requirements: Bachelor's in Life Sciences or related field; 7+ years in medical or regulatory writing within biotech, pharma, or CRO sectors; demonstrated leadership in complex document production; strong knowledge of global regulatory guidelines (FDA, EMA, ICH). Preferred: advanced degrees (MS, PharmD, PhD), expertise in regulatory processes, and proficiency with electronic document management systems. High-value specifics involve supporting rare disease therapeutics, clinical development phases, and global regulatory compliance. The role involves strategic input on process improvements and standardization, with up to 10% domestic and international travel. Work setup: primarily remote with face-to-face interactions in San Diego.