Principal Medical Writer

Overview

In this role you will lead high-quality medical writing for complex clinical and regulatory projects at GSK. You will collaborate with clinical, regulatory, statistical, and cross-functional teams to deliver clear, regulatory-ready documents. You will act as a writing expert, drive process improvements, and ensure compliance with ICH/GCP standards. This is a chance to shape pivotal submissions and support the HIV portfolio at a global scale.

Responsibilities

• Lead authoring and strategic planning for clinical and regulatory documents (protocols, CSRs, briefing documents, submission dossiers)
• Manage end-to-end writing projects with contributors, timelines, and quality checks
• Translate complex clinical and statistical data into clear scientific narratives for diverse audiences
• Act as SME on medical writing standards, document structure, and regulatory expectations
• Drive process improvements, support KPI tracking, audit readiness and compliance activities

Key requirements

• Bachelor’s degree in life sciences, health sciences, or a scientific field
• 5+ years of experience in medical or regulatory writing in pharma/healthcare
• 3+ years of experience with regulatory dossier development and CTD module documents
• 3+ years of independently authoring clinical protocols, CSRs, and regulatory submission documents

• Strong written and verbal communication
• Excellent attention to detail
• Effective collaboration across cross-functional and multicultural teams
• CTD dossiers
• ICH guidelines
• GCP

…