Senior Director, Medical Writing

Senior Director, Medical and Scientific Writing responsible for leading cross-functional development of high-quality regulatory and scientific documents (e.g., clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analyses, safety updates, annual reports, narratives) and for building scalable writing infrastructure, templates, and standards. Collaborates across Clinical, Regulatory, Quality, Medical Affairs, and CMC to interpret non-clinical and clinical data, develop messaging, manage timelines, and oversee internal/external authors and vendors. Ensures content adheres to ICH/FDA/EMEA and Annexon guidelines; supports scientific communications (manuscripts, abstracts, posters) for congresses and external publication; leads budget, resourcing, and process improvements to drive efficiency and quality. Requires a Bachelor’s/Master’s or PhD-equivalent with 10+ years of scientific/medical writing experience. Location: Brisbane, CA with remote opportunities and preference for SF Bay Area."