Director Medical Writing Asset Lead 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.

Job Purpose

Are you energized by a medical writing and submissions role that allows you to shape clinical document strategy and accelerate product approvals? If so, this Director Medical Writing Asset Lead role could be an exciting opportunity to consider.

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 and submissions strategy for one or more assets (main asset Hepatology). 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.

This is a highly visible medical writing role, that will provide YOU the opportunity to lead key activities to progress YOUR career. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization.

Key responsibilities:

• Providing key contributions to clinical document strategy for one or more assets throughout the life cycle of drug development. Documents in scope include but are not limited to 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.
• Leading matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed.
• Planning and successfully delivering large submissions independently, effectively recommending innovative methods and solutions for achieving accelerated timelines.
• Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met.
• Acting as lead author on submissions, effectively organizing content and arguments in complex clinical submission documents.
• Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources.
• Driving, promoting and implementing key organizational process improvement initiatives.
• Prioritizing and meeting multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix.
• Promoting leadership behaviors that support GSK values.

Why you?

Basic Qualifications:

• PhD, PharmD, MPH, MSc, or other post-graduate degree.
• Substantial experience in clinical regulatory writing and regulatory submissions in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
• Strong experience in project management, planning, communication, and demonstrated matrix leadership to deliver results.

Preferred Qualifications:

• Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World.
• Experience in Hepatology therapy area.
• Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.
• 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.

Working arrangements

This role has a hybrid working model. You will work on-site 2/3 days per week as agreed with your manager to support collaboration and team needs. For an exceptional candidate remote flexibility may be considered in UK/Belgium/Canada only if you are not within a reasonable distance from the local office.

Why GSK?

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.

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.