Senior Director, Medical Writing
Annexon Biosciences
August 19, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Responsibilities:
- Lead and direct critical writing for clinical/regulatory documents (e.g., protocols, IBs, CSRs, INDs/CTDs/amendments, analysis/development plans, safety updates/annual reports, narratives/summaries, briefing books, and other Research/Pre-Clinical/CMC/Clinical/Regulatory documents).
- Critically analyze non-clinical and clinical data to develop strategy, conclusions, and messaging; perform literature/scientific database searches as needed.
- Serve as a thought leader to develop writing strategy/approach, ensuring consistency and efficiency in how messaging and documents are built and organized.
- Build scalable medical/scientific writing infrastructure (templates, formats, processes/standards, style guides, workflow/operating procedures) with resourcing and manage the department budget; develop realistic timelines.
- Collaborate with internal/external authors and vendors; oversee operational considerations, expectations, milestones, and deliverables.
- Ensure document content and style meet ICH/FDA/EMEA and applicable requirements.
Qualifications / Required:
- BS/MS or PhD (or equivalent) in a scientific discipline; 10+ years of scientific/medical/technical writing experience.
- Track record producing high-quality scientific/medical documents for internal/external distribution.
- Ability to translate complex data into clear written summaries/positions for multiple audiences.
- Strong collaboration, prioritization, judgment, and problem-solving in a fast-paced environment.
- Superior attention to detail (grammar, syntax, scientific accuracy); experience building infrastructure/template repositories is a plus.
- Proficiency with document creation/sharing/editing and data visualization tools (e.g., Microsoft Office, Adobe, SharePoint, Tableau, etc.).
Benefits:
- Flexible work schedules and remote opportunities.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits).
- Lead and direct critical writing for clinical/regulatory documents (e.g., protocols, IBs, CSRs, INDs/CTDs/amendments, analysis/development plans, safety updates/annual reports, narratives/summaries, briefing books, and other Research/Pre-Clinical/CMC/Clinical/Regulatory documents).
- Critically analyze non-clinical and clinical data to develop strategy, conclusions, and messaging; perform literature/scientific database searches as needed.
- Serve as a thought leader to develop writing strategy/approach, ensuring consistency and efficiency in how messaging and documents are built and organized.
- Build scalable medical/scientific writing infrastructure (templates, formats, processes/standards, style guides, workflow/operating procedures) with resourcing and manage the department budget; develop realistic timelines.
- Collaborate with internal/external authors and vendors; oversee operational considerations, expectations, milestones, and deliverables.
- Ensure document content and style meet ICH/FDA/EMEA and applicable requirements.
Qualifications / Required:
- BS/MS or PhD (or equivalent) in a scientific discipline; 10+ years of scientific/medical/technical writing experience.
- Track record producing high-quality scientific/medical documents for internal/external distribution.
- Ability to translate complex data into clear written summaries/positions for multiple audiences.
- Strong collaboration, prioritization, judgment, and problem-solving in a fast-paced environment.
- Superior attention to detail (grammar, syntax, scientific accuracy); experience building infrastructure/template repositories is a plus.
- Proficiency with document creation/sharing/editing and data visualization tools (e.g., Microsoft Office, Adobe, SharePoint, Tableau, etc.).
Benefits:
- Flexible work schedules and remote opportunities.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits).