Director Medical Writing Asset Lead in London

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.

As Medical Writing Asset Lead Director, you will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide the medical writing strategy for one or more assets. You will design and deliver high-quality fit for purpose clinical documents for global regulatory submissions, plan for efficient and accelerated ways of working, and contribute to key organizational process improvements. 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.

Key Responsibilities

• Provide key contributions to clinical document strategy for one or more assets throughout the life cycle of drug development, including protocols, study reports, briefing documents, CTC summaries and responses to regulatory authority questions.
• Lead matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed.
• Plan and deliver large submissions independently, recommending innovative methods and solutions for accelerated timelines, assessing interdependencies, managing problems affecting timelines, and ensuring a global approach as appropriate.
• Act as lead author on submissions, organizing content and arguments in complex clinical documents.
• Propose resourcing solutions for major projects, including number of FTEs and best use of internal and external resources.
• Contribute to development of training materials and provide mentoring on regulatory requirements, medical writing processes, and submission planning.
• Drive, promote and implement key organizational process improvement initiatives, generating ideas for simplification and improvement.
• Prioritize and meet multiple deadlines with attention to detail, demonstrating high performance standards.
• Promote leadership behaviors that support GSK values.

Basic Qualifications

• Postgraduate degree (e.g., PhD, PharmD, MSc, MPH) in life sciences, pharmacy, medicine, public health or related discipline.
• Extensive experience in clinical regulatory writing in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
• Extensive experience in project management, planning, communication, and demonstrated matrix leadership to deliver results.
• Excellent understanding of clinical operations/medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval.
• Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities.

Preferred Qualifications

• Experience delivering accelerated submissions for EU, US, China, Japan and Rest of World.
• Experience in clinical pharmacology applied to clinical development and PK/PD interpretation.
• Demonstrated cross-functional collaboration with effective communication skills and experience building networks and influencing partners and stakeholders at all levels of the organization.

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.