Senior Medical Writer

About the role

Lead the planning and writing of clinical regulatory documents for client drug development programs, coordinating cross-functional contributors under tight timelines.

What you will do

• Lead document execution, including project management, timelines, and communication
• Coordinate client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure documents follow client processes, templates, and instructional materials
• Guide document message development and interpret data to create shell documents
• Plan and lead kickoff and comment resolution meetings, following up on review feedback
• 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 field
• Flexibility to work across multiple therapeutic areas
• Familiarity with lean authoring and structured content management
• Knowledge of ICH and US regulatory requirements for clinical and regulatory documents

Nice to have

• Oncology, infectious disease, or vaccine experience
• Working knowledge of ex-US regulatory requirements