Executive Director, Medical Writing

The role

The Executive Director, Medical and Scientific Writing provides strategic leadership and oversight of medical and scientific writing across the organization. This person will lead the strategy, authoring, and development of key documents and build scalable writing infrastructure.

What you will do

• Provide strategic leadership and oversight of all critical writing activities.
• Develop and produce deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, and safety updates.
• Analyze and interpret non-clinical and clinical data to develop strategy and messaging.
• Perform literature and scientific database searches.
• Serve as a senior strategic thought leader on cross-functional teams.
• Lead the development and evolution of a scalable medical and scientific writing infrastructure.
• Provide oversight of departmental resources and budget.
• Collaborate with internal and external authors and vendors.
• Ensure document content and style adhere to Annexon guidelines and ICH/FDA/EMEA requirements.

Required qualifications

• Bachelor’s/Master’s degree or Ph.D./equivalent in a scientific discipline
• Minimum of 12 years of progressive scientific, medical, or technical writing experience
• Demonstrated leadership of complex writing initiatives
• Strong background and track record of leading the development of high quality scientific and medical documents
• Ability to translate complex data into clear, understandable, and compelling written summaries
• Ability to work, communicate and collaborate with colleagues and external stakeholders
• Capability and comfort with prioritizing multiple projects, deliverables, and timelines
• Superior attention to detail and thoroughness related to processes, consistency, grammar, syntax, and scientific accuracy
• Exceptional computer skills and familiarity with Microsoft Office, Adobe, Sharepoint, Graphpad, Tableau, and Spotfire

Nice to have

• Prior work history at a biotech or pharmaceutical company
• Smaller company environment ideal
• Prior experience building a scientific and medical writing infrastructure and template repository

Benefits

• Flexible work schedules
• Remote opportunities
• Shuttle service from BART, CalTrain and the Ferry
• Competitive base salary
• Equity participation
• Employee stock purchase plan
• Medical
• Dental
• Vision
• 401(k)
• Flexible spending plans

About the company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for neuroinflammatory diseases. The company is headquartered in Brisbane, CA.