Manager, Strategic Labelling and Development

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About the role

Manager, Strategic Labelling & Development   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 US-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.   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. •   • Experience with stakeholder management and collaboration skills, including the ability to work effectively in complex matrix teams and

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