Senior Medical Writer

About the role

Leads the planning and writing of clinical and regulatory documents for client drug development programs. Works across teams and with sponsors to deliver high quality submissions on tight timelines.

What you will do

• Lead document execution, including building, tracking and sharing project timelines
• Coordinate client contributors, stakeholders and internal resources such as quality control and publishing
• Make sure documents follow client processes, templates and instructional materials
• Guide message development with the client and interpret data to create shell documents
• Plan and run kickoff meetings and comment resolution sessions, following up on open review feedback
• Keep messaging, formatting and presentation consistent across client programs and run literature searches

What they look for

• Five or more years as a medical writer in a CRO, biotech or pharmaceutical setting
• Bachelor degree or higher in a relevant field
• Able to follow established processes and document templates
• Familiarity with lean authoring and structured content management
• Knowledge of ICH and US requirements for clinical and regulatory documents, plus strong English communication

Nice to have

• Oncology, infectious disease or vaccine experience
• Working knowledge of regulatory requirements outside the US
• Comfort with new tools and technologies