Director Medical Writing Asset Lead, Oncology

GSK•Upper Providence, PA

About The Position

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.

Requirements

Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline
Significant experience in clinical regulatory medical writing within the pharmaceutical or biotech industry
Experience in authoring and leading regulatory clinical documents for global oncology FDA and/or EMA 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.

Nice To Haves

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.

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 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.