Senior Manager, Medical Writing

Role: Senior Manager, Medical Writing, responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents supporting drug development and regulatory submissions. Objectives include ensuring scientific accuracy, regulatory compliance, and timely delivery of high-quality documents across all clinical phases. Responsibilities encompass collaboration with cross-functional teams, document lifecycle management, data interpretation, and process improvements in medical writing standards. Qualifications: Bachelor's in Life Sciences or related field; 7+ years in medical/regulatory writing within biotech, pharma, or CRO sectors; proven leadership in complex document authoring; strong knowledge of global regulatory guidelines (FDA, EMA, ICH). Preferred: Advanced degrees (MS, PharmD, PhD), experience with clinical, regulatory, and scientific documentation, proficiency with Veeva and electronic document systems, and project management skills. High-Value: Focus on rare disease therapies, supporting clinical and regulatory documentation, with familiarity in drug development processes, global regulatory standards, and a collaborative, fast-paced environment. Work setup requires some face-to-face interaction in San Diego with travel up to 10% domestically and internationally.