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Director Medical Writing Asset Lead
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.
Find out more: Our approach to R&D
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:
These responsibilities include some of the following:
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. Assessing and adapting to interdependences of various contributing functions and managing problems affecting timelines as necessary. Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met. Providing guidance and facilitation to submission teams in development of detailed submission plans.
Acting as lead author on submissions. Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources.
Actively contributing to development of training materials for therapeutic area and providing mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams.
Driving, promoting and implementing key organizational process improvement initiatives. Proactively generating ideas for simplification and improvement taking advantage of opportunities that arise and challenging the status quo. Incorporating, promoting and encouraging the adoption of technology for clinical documents within medical writing and the stakeholder landscape.
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:
We are looking for professionals with these required skills to achieve our goals:
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:
If you have the following characteristics, it would be a plus:
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 consider in UK/Belgium/Canada only if you are not within a reasonable distance from the local office.
How to apply
We welcome applicants from all backgrounds and encourage you to apply. Please tell us how your experience and values will help you succeed in this role and contribute to our mission of uniting science, technology and talent to get ahead of disease together.
Closing Date: 22nd August 2026
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Skills
Clinical Development, Clinical Trial Designs, Communication, Customer Service, Decision Making, Emotional Intelligence, Influencing Without Authority, Learning Agility, Literature Reviews, Medical Writing, Pharmaceutical Industry, Presentation Techniques, Regulatory Submissions, Scientific Writing, Strategic Thinking
Belgium Salary Range / Fourchette salariale – Belgique: EUR 119,250 to EUR 198,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.
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.
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.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.
Please note should your enquiry 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
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