Manager, Labelling Strategy and Development in London

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 practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Are you an enthusiastic regulatory professional with experience or an interest in developing patient and prescriber information while pursuing a career in a global pharmaceutical company? If so, GSK currently has opportunities in its Global Regulatory Affairs (GRA)- Labelling department, within Research and Development, and this Labelling role may be an ideal opportunity for you to explore. At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life. Ensuring these products are correctly prescribed and used is essential, and that’s where our labelling team is key. The Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Global Datasheet, which contains information for prescribers and patients.

As a Labelling Manager in the UK-based team, you will help us support our exciting pipeline of new products. As a global position, you will be providing labelling support to colleagues in markets worldwide. This may include work on the US PI; European SmPC, patient information leaflet and label; and prescribing/patient information for other major international markets, including Asia Pacific and key emerging markets.

Our labelling development team supports a product during development and throughout its early lifecycle, and we are the authors of Global Datasheets for GSK products. You will liaise with colleagues in clinical, safety and other regulatory functions to ensure that the Prescribing Information and Patient Leaflets accurately state the Company's medical and scientific position regarding the safe and effective use of a GSK product. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead the development, authoring and maintenance of Global Datasheets for new medicines, product line extensions and early lifecycle products, ensuring labelling content accurately reflects GSK’s medical and scientific position.
• Manage local prescribing and patient information through development and early post-approval stages, including US Prescribing Information, EU SmPC, patient information leaflets, labels and other regional product information where applicable.
• Partner with colleagues in global markets to support timely and consistent implementation of Global Datasheets into country and regional prescribing/patient information, while managing key country labelling differences where required.
• Author regulatory responses and supporting documentation relating to prescribing and patient information, including materials for Regulatory Authorities and Labelling Governance Committees.
• Interface with key labelling, regulatory, clinical, safety, governance and operational stakeholders across GSK, helping to align labelling strategy, resolve issues and support decision-making in a complex matrix environment.
• Maintain labelling documentation, data and processes in relevant systems and databases, including Veeva Vault, while mentoring colleagues on labelling processes, supporting governance meetings and representing GSK externally where required.

Why you?

Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals:

• Degree in Pharmacy, Life Sciences, Biomedical Sciences or related discipline with experience in a relevant scientific, pharmacy or healthcare-related field.
• Strong written and verbal English communication skills with a focus on clarity and accuracy.
• Excellent stakeholder management and collaboration skills, including the ability to work effectively in complex matrix teams and meet internal and external deadlines.
• Sound judgement and decision-making skills, with the ability to interpret complex scientific information, assess risks and benefits, draw on insight from multiple sources, and resolve conflicts appropriately.
• Ability to collaborate effectively in cross-functional environments.

Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced degree, such as MSc, MPharm, PhD or equivalent.
• Relevant labelling or related experience across pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic areas.
• Strong track record of authoring clear, accurate scientific labelling text, prescribing information or patient-facing content for healthcare professionals and patients.
• Proactive mindset with a focus on performance, continuous improvement, flexibility, leadership and challenging ways of working to improve processes.
• Experience working in oncology.

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.

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.