Responsibilities:
- Lead all critical writing activities across Annexon; author and develop high-quality deliverables including clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and 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 (internal/external) to develop strategy, conclusions, and messaging; perform literature/scientific database searches as needed.
- Serve as a key thought leader to develop strategy/approach and ensure consistency and efficiency in how messaging and documents are built and organized.
- Build scalable medical/scientific writing infrastructure (resourcing emphasis): formats, templates, processes/standards, style guides, workflow, and operating procedures; manage department budget and develop realistic writing timelines.
- Collaborate with internal/external authors and vendors as needed; oversee operational considerations and ensure milestone/deliverable awareness.
- Ensure document content and style adhere to Annexon guidelines and ICH/FDA/EMEA (or other applicable) requirements.
Required qualifications:
- Bachelorβs/Masterβs in a scientific discipline or Ph.D. (or equivalent) and 10+ years of scientific/medical/technical writing experience.
- Strong track record producing high-quality scientific/medical documents for internal/external distribution.
- Ability to translate complex data into clear written summaries/interpretations/positions for multiple audiences.
- Team-collaboration and transparent, data-driven communication.
- Strong prioritization and judgment across multiple projects and timelines.
- Superior attention to detail (process, consistency, grammar/syntax, scientific accuracy).
- Exceptional computer skills with document creation/editing and data visualization tools (e.g., Microsoft Office/Adobe; SharePoint/Graphpad/Tableau; Spotfire).
Preferred qualification:
- Prior work history at a biotech/pharmaceutical company (smaller company environment ideal).
Benefits:
- Flexible work schedules, remote opportunities, work-life balance support.
- Shuttle service from BART, CalTrain and the Ferry.
- Competitive base salary, equity, employee stock purchase plan; comprehensive health benefits (medical/dental/vision), 401(k), flexible spending plans.
Salary range: $257,000β$286,000 USD.
Location:
- Brisbane, CA (preference for San Francisco Bay Area).