Lead Medical Writer - Clinical & Regulatory Strategy

GSK; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits program

Job summary

GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences.

This role requires strong collaboration and communication skills to work with cross-functional teams. Benefits include a comprehensive program for US employees, along with opportunities for professional growth.

Qualifications

• 5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
• 3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
• Strong understanding of ICH guidelines and Good Clinical Practice (GCP).

Responsibilities

• Lead authoring and strategic planning for clinical and regulatory documents.
• Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks.
• Translate complex clinical data into clear scientific narratives.

Skills

Medical writing

Regulatory writing

Communication

Collaboration

Education

Bachelor’s degree in life sciences

Job description

GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences.

This role requires strong collaboration and communication skills to work with cross-functional teams. Benefits include a comprehensive program for US employees, along with opportunities for professional growth.