Senior Director, Medical Writing

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.

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