Senior Medical Writer (FSP)

About the role

Works inside client study teams, coordinating writing tasks across departments and keeping documents on time and on budget. Good work means clear, accurate science that holds up to regulatory and editorial review.

At a glance

What you will do

• Lead writing of study documents such as protocols, amendments, clinical study reports and patient narratives
• Manage writing activities for individual studies and coordinate with other departments with little supervision
• Handle client comments and lead the resolution of review feedback
• Follow ICH E3 and other regulatory standards, plus client templates and style guides
• Review statistical analysis plans and table, figure and listing specs for content and format

What they look for

• Experience writing clinical and regulatory documents across the drug development cycle
• Knowledge of ICH E3 guidelines and regulatory submission formats including eCTD and NDA
• Ability to coordinate quality and editorial reviews and manage source documentation
• Skill at peer reviewing documents for scientific content, clarity and consistency
• Good working relationships with clients, biostatistics, data management and regulatory colleagues