Director Medical Writing Asset Lead, Oncology

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Position Summary

You will lead medical writing for one or more development oncology assets, with accountability for asset-level medical writing strategy from planning to delivery. This is a highly visible, strategic role, partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other functions in a matrix environment to shape regulatory strategy and deliver clear, high-quality, fit for purpose clinical documents for global regulatory interactions and submissions.

You will balance scientific rigor with practical execution, champion efficient and accelerated ways of working, and proactively identify opportunities to simplify document lifecycle, reduce risk and strengthen submission quality across the asset lifecycle. We value collaborative leaders who apply sound judgement, practical problem solving and inclusive coaching to enable high-performing teams and successful outcomes.

This role offers meaningful impact, visible growth opportunities, and a chance to unite science, technology and talent to get ahead of disease together.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

• Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.

• Own and drive asset-level medical writing strategy, ensuring alignment with development and regulatory objectives across regions

• Lead and coach multi-disciplinary matrix teams and external vendors to meet quality, timeline and budget expectations.

• Plan and deliver complex and accelerated global submissions, recommending innovative approaches to achieve ambitious timelines while proactively managing cross-functional interdependencies and risks.

• Create and maintain submission and document lifecycle plans. Advise teams on fit-for-purpose approaches and risk mitigation.

• Act as lead author or senior reviewer for complex submission documents and regulator queries, ensuring clear scientific positioning and compelling regulatory narratives.

• Define and recommend resourcing strategies for major projects, including optimal use of internal teams and external vendors

• Drive process and technology improvements that increase consistency, efficiency and document quality while constructively challenging the status quo.

• Mentor colleagues and build oncology medical writing capability through training, clear feedback and practical guidance, including contribution to training materials.

We welcome applicants who value clear communication, collaboration and practical leadership.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline

• Minimum 10 years' experience in clinical regulatory medical writing within the pharmaceutical or biotech industry

• Experience in oncology

• Experience in authoring and leading regulatory clinical documents for global submissions

• Experience in leading multi-disciplinary, matrix teams and managing external medical writing vendors

• Experience in program management i.e. project planning and delivery skills, including risk identification and timeline management

• Written and verbal communication skills with the ability to present complex scientific content clearly.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Experience delivering complex and accelerated submissions to major health authorities across regions

• Experience coaching, mentoring and developing training materials

• Familiarity with global regulatory guidelines and Good Clinical Practice principles

• Experience implementing medical writing technologies and process improvements

• Experience working across multiple locations in a matrix organization.

What success looks like

You enable timely, high-quality global submissions for oncology assets, building confidence with internal stakeholders. You lead accelerated and innovative submission strategies while maintaining scientific rigor and compliance. You strengthen internal capability and vendor partnerships. You simplify documents lifecycles and introduce practical improvements that reduce risk and increase efficiency across the organization.

Apply now

If this role fits your experience and purpose, we would like to hear from you. Please submit your CV and a short cover letter describing your relevant experience and why this role matters to you.

We are committed to inclusion and welcome applicants from all backgrounds. If you need adjustments during the recruitment process, please tell us when you apply.

Job Application End Date

Monday March 9th 2026 EOD CET

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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.

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