Director Medical Writing Asset Lead, Oncology

Site Name: GSK HQ, Bangalore, Belgium-Wavre, Canada - Ontario - Mississauga - Milverton Drive, Italy - Siena, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw

Posted Date: Mar

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 that is ambitious for patients, accountable for impact, and committed to doing the right thing, focusing efforts on accelerating significant assets that meet patients’ needs.

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 that partners 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.

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

Responsibilities

• 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, 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.

Basic Qualifications

• Postgraduate degree (PhD, PharmD, MSc, MPH, or related discipline) in life sciences, pharmacy, medicine, public health, or related field.
• Significant experience in clinical regulatory medical writing within the pharmaceutical or biotech industry.
• Experience authoring and leading regulatory clinical documents for global oncology FDA and/or EMA submissions.
• Experience leading multi‑disciplinary, matrix teams and managing external medical writing vendors.
• Experience in program management (project planning and delivery, risk identification, and timeline management).
• Strong written and verbal communication skills with the ability to present complex scientific content clearly.

Preferred Qualifications

• 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, strengthen internal capability and vendor partnerships, and simplify document lifecycles to reduce risk and increase efficiency.

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.

Equal Opportunity Employer

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, military service, or any basis prohibited under federal, state or local law.

Adjustments

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Job Application End Date

Monday 13th April 2026