Sr Manager, Medical Writing

Role: Senior Manager, Medical Writing supporting regulatory documents for autoimmune disease programs, focusing on FDA interactions and clinical development. Responsibilities: author, edit, and finalize complex regulatory submissions, including FDA briefing packages, clinical protocols, and synopses; lead document development timelines; collaborate with cross-functional teams (Clinical Development, Regulatory Affairs, Clinical Operations) to synthesize scientific data; ensure compliance with FDA, ICH, and GCP standards; participate in regulatory strategy meetings. Requirements: PhD, PharmD, MD, MS, or equivalent in Life Sciences or related field; 10+ years in biotech/pharma medical writing with expertise in autoimmune diseases, especially MS; proven track record in independently authoring FDA regulatory documents, such as briefing packages supporting RMAT or Breakthrough Therapy Designation; strong understanding of regulatory guidelines; excellent communication and project management skills; ability to manage multiple projects with minimal oversight. HighValue: autoimmune diseases (MS, PDS), FDA regulatory submissions, briefing documents supporting breakthrough designations, clinical protocols, cross-functional collaboration. WorkSetup: remote (West Coast hours preferred). No travel specified.