Senior Medical Writer

About the role

A senior writer joins a medical writing team to plan and draft clinical and regulatory documents for drug development programmes, working with client teams under tight timelines.

What you will do

• Lead document execution, including building and sharing project timelines
• Coordinate client contributors, stakeholders and internal resources such as quality control and publishing
• Interpret data and prepare shell documents to support authoring
• Plan and run kickoff meetings and comment resolution sessions
• Check documents for consistency in messaging, formatting and presentation across programmes
• 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
• Experience drafting clinical study reports, protocols, amendments, investigator brochures and module 2 and module 5 documents
• Ability to work across several 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 regulatory requirements outside the US