Sponsor Dedicated - Sr Medical Writer (CSR, Protocols, IB and Reg documents)

Overview

Lead medical writing deliverables for clinical and regulatory documents, coordinating reviews and stakeholders across clinical development functions.

What you'll do

• Lead completion of clear and accurate medical writing deliverables.
• Manage writing activities for individual studies with minimal supervision.
• Prepare protocols, clinical study reports, investigator brochures, regulatory submissions, and related documents.
• Coordinate quality, editorial, and team document reviews.
• Review statistical analysis plans and table, figure, and listing specifications.
• Resolve client comments and escalate issues as appropriate.
• Mentor less experienced medical writers on complex projects.

What you'll need

• 3–5 years of relevant regulatory writing experience.
• Experience in the biopharmaceutical, medical device, or contract research organization industry.
• Strong understanding of EMA, FDA, and ICH regulations and other regulatory guidelines.
• Experience writing relevant document types.
• Excellent English grammar and clear communication skills.
• Familiarity with the AMA Manual of Style.

Details

• Remote location.
• Minimal travel may be required, less than 25%.