Senior Director, Medical Writing
Annexon Biosciences
3 months ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Position: Senior Director, Medical and Scientific Writing
Responsibilities:
- Lead and direct critical writing activities across Annexon; author and produce high-quality documents (clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis/development plans, safety updates/annual reports, narratives/summaries, briefing books, and other Research/Pre-Clinical/CMC, Clinical, and Regulatory documents).
- Analyze and interpret non-clinical and clinical data to develop strategy, conclusions, and messaging; perform literature/scientific database searches as needed.
- Serve as a thought leader to ensure consistency and efficiency in how messaging and documents are built and organized.
- Build scalable medical/scientific writing infrastructure (resourcing emphasis): develop formats/templates/processes/standards, style guides, workflow, operating procedures; manage department budget; develop realistic timelines.
- Collaborate with internal/external authors/vendors to support deliverables; oversee operational considerations and ensure awareness of expectations, milestones, and deliverables.
- Ensure document content and style adhere to Annexon guidelines and ICH/FDA/EMEA (or other applicable) requirements.
Education/Experience/Skills:
- Required: Bachelor’s/Master’s (or Ph.D./equivalent) in a scientific discipline; minimum 10 years of scientific/medical/technical writing experience.
- Preferred: Prior biotech/pharma experience (smaller company environment ideal).
- Strong track record producing high-quality scientific/medical documents for internal/external distribution.
- Strategic, flexible thinker who translates complex data into clear written summaries/interpretations/positions for multiple audiences.
- Team collaboration with transparency; data-driven, fast-paced environment.
- Ability to prioritize multiple projects/timelines; identify opportunities for process/efficiency improvements.
- Superior attention to detail (process, consistency, grammar/syntax, scientific accuracy); experience building writing infrastructure/template repository is a plus.
- Exceptional computer skills; familiarity with Microsoft Office/Adobe; SharePoint/GraphPad/Tableau; and data visualization tools (e.g., Spotfire).
- Entrepreneurial spirit, integrity, independence, transparency; exemplifies core values.
Benefits:
- Flexible work schedules and remote opportunities; work-life balance.
- 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.
Responsibilities:
- Lead and direct critical writing activities across Annexon; author and produce high-quality documents (clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis/development plans, safety updates/annual reports, narratives/summaries, briefing books, and other Research/Pre-Clinical/CMC, Clinical, and Regulatory documents).
- Analyze and interpret non-clinical and clinical data to develop strategy, conclusions, and messaging; perform literature/scientific database searches as needed.
- Serve as a thought leader to ensure consistency and efficiency in how messaging and documents are built and organized.
- Build scalable medical/scientific writing infrastructure (resourcing emphasis): develop formats/templates/processes/standards, style guides, workflow, operating procedures; manage department budget; develop realistic timelines.
- Collaborate with internal/external authors/vendors to support deliverables; oversee operational considerations and ensure awareness of expectations, milestones, and deliverables.
- Ensure document content and style adhere to Annexon guidelines and ICH/FDA/EMEA (or other applicable) requirements.
Education/Experience/Skills:
- Required: Bachelor’s/Master’s (or Ph.D./equivalent) in a scientific discipline; minimum 10 years of scientific/medical/technical writing experience.
- Preferred: Prior biotech/pharma experience (smaller company environment ideal).
- Strong track record producing high-quality scientific/medical documents for internal/external distribution.
- Strategic, flexible thinker who translates complex data into clear written summaries/interpretations/positions for multiple audiences.
- Team collaboration with transparency; data-driven, fast-paced environment.
- Ability to prioritize multiple projects/timelines; identify opportunities for process/efficiency improvements.
- Superior attention to detail (process, consistency, grammar/syntax, scientific accuracy); experience building writing infrastructure/template repository is a plus.
- Exceptional computer skills; familiarity with Microsoft Office/Adobe; SharePoint/GraphPad/Tableau; and data visualization tools (e.g., Spotfire).
- Entrepreneurial spirit, integrity, independence, transparency; exemplifies core values.
Benefits:
- Flexible work schedules and remote opportunities; work-life balance.
- 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.