View Principal Medical Writer

Principal Medical Writer

Location: Stevenage, UK (with planned relocation to Cambridge by early 2029)

Remote type: Hybrid (Remote & On-site)

Time type: Full time

Job Requisition ID: 439037

In this role you will

• Author and deliver high-quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
• Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.
• Partner within cross-functional, matrix teams to produce fit-for-purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
• Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.
• Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well-structured regulatory narratives.
• Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation.

Basic Qualifications & Skills:

• PhD or equivalent relevant experience within the life sciences.
• Advanced experience in clinical regulatory medical writing within the pharmaceutical industry.
• Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents.
• Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data.
• Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments.
• Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills.

Closing Date for Applications – 17/08/2026

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.