Associate Director, Medical Writing
Acadia Pharmaceuticals
August 13, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Primary Responsibilities
- Prepare clinical/regulatory documents (e.g., briefing books, cover letters, summary documents, investigator brochures, clinical study reports, protocols) from planning/storyline through writing, review/approval facilitation, and formatting.
- Manage document timelines/process; communicate and track deliverables, writing process, and due dates.
- Convert relevant data into documents meeting applicable regulatory requirements; develop submission strategy and section outlines; assign content partners.
- Serve as writing lead; coordinate with cross-functional internal/external teams to ensure accurate, timely, scientifically justified deliverables.
- Ensure electronic document deliverables are processed/compiled per timelines and templates; interpret source information; ensure completeness and goals are met.
- Follow ICH and governing-body formatting/conventions; resolve writing issues strategically; maintain regulatory/compliance currency; provide guidance/oversight to contract writers/vendors when needed.
Education/Experience/Skills
- Master’s degree (PhD preferred); or equivalent education/experience.
- ~5 years progressively responsible science/medical writing focused on clinical/regulatory documents (pharma/biotech preferred). AMWA certification strongly preferred.
- Exceptional ability to convert scientific data into clear, well-structured narratives; strong self-editing.
- Knowledge of US/ICH/international regulations; Common Technical Document templates; IND/NDA/MAA expectations; electronic document/publishing systems.
- Advanced Windows skills (word processing, flow diagrams, spreadsheets); ability to travel domestically/internationally as needed.
Benefits (US-based)
- Medical/dental/vision; employer-paid life, disability, business travel and EAP; 401(k) 1:1 match up to 5%; stock purchase plan; 15+ vacation days; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance.
- Prepare clinical/regulatory documents (e.g., briefing books, cover letters, summary documents, investigator brochures, clinical study reports, protocols) from planning/storyline through writing, review/approval facilitation, and formatting.
- Manage document timelines/process; communicate and track deliverables, writing process, and due dates.
- Convert relevant data into documents meeting applicable regulatory requirements; develop submission strategy and section outlines; assign content partners.
- Serve as writing lead; coordinate with cross-functional internal/external teams to ensure accurate, timely, scientifically justified deliverables.
- Ensure electronic document deliverables are processed/compiled per timelines and templates; interpret source information; ensure completeness and goals are met.
- Follow ICH and governing-body formatting/conventions; resolve writing issues strategically; maintain regulatory/compliance currency; provide guidance/oversight to contract writers/vendors when needed.
Education/Experience/Skills
- Master’s degree (PhD preferred); or equivalent education/experience.
- ~5 years progressively responsible science/medical writing focused on clinical/regulatory documents (pharma/biotech preferred). AMWA certification strongly preferred.
- Exceptional ability to convert scientific data into clear, well-structured narratives; strong self-editing.
- Knowledge of US/ICH/international regulations; Common Technical Document templates; IND/NDA/MAA expectations; electronic document/publishing systems.
- Advanced Windows skills (word processing, flow diagrams, spreadsheets); ability to travel domestically/internationally as needed.
Benefits (US-based)
- Medical/dental/vision; employer-paid life, disability, business travel and EAP; 401(k) 1:1 match up to 5%; stock purchase plan; 15+ vacation days; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance.