Senior Medical Writer

About the role

A senior writer role leading the planning and drafting of clinical and regulatory documents for drug development programs, working with cross-functional client teams under tight timelines.

What you will do

• Lead document execution, including building, tracking and sharing timelines
• Coordinate client contributors and internal resources such as quality control and publishing
• Make sure document work follows client processes, templates and guidance
• Guide message development with clients and interpret data to draft shell documents
• Plan and run kickoff meetings and comment resolution sessions
• Conduct literature searches and peer quality control reviews as needed

What they look for

• Five or more years as a medical writer in a CRO, biotech or pharmaceutical setting
• Bachelor's degree or higher in a relevant discipline
• Experience drafting clinical study reports, protocols, amendments, investigator brochures and module 2 or module 5 documents
• Comfort with multiple therapeutic areas and established document processes and templates
• Knowledge of ICH and US regulatory requirements for clinical and regulatory documents
• Proficiency with Microsoft Word and other Office applications

Nice to have

• Oncology, infectious disease or vaccine experience
• Familiarity with lean authoring and structured content management
• Working knowledge of regulatory requirements outside the US