Responsibilities include: Lead and direct all aspects of critical writing activities within Annexon, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and development plans, safety updates and annual reports, narratives/summaries, briefing books, and additional Research/Pre-Clinical/CMC, Clinical and Regulatory documents in support of our programs. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Clinical, Regulatory, Quality, Medical Affairs, Commercial and CMC departments to author and drive development of key documents in support of all of our programs.