Principal Medical Writer

GSK

3d•Hybrid

About The Position

We are seeking an experienced professional with advanced medical writing expertise who can independently manage complex regulatory writing projects. This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions. Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness. Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements. Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs. Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives. Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation. 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. 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 [email protected] 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 Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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Requirements

PhD or equivalent relevant experience within the life sciences.
Advanced experience in clinical regulatory medical writing within the pharmaceutical industry.
Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents.
Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data.
Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments.
Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills.

Responsibilities

Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.
Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.
Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives.
Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation.