Global Labelling Strategy Manager

GSK; North East; On-site; GBP 105,000 - 175,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Job summary

GSK seeks a Manager of Strategic Labelling & Development to lead and maintain Global Datasheets, guiding prescribing information, patient leaflets and labels across markets. You will collaborate with global teams to ensure accurate, science-based labelling reflecting GSK positions during development and early lifecycle stages.

The role emphasizes stakeholder management, regulatory writing and governance, with mentoring of colleagues in labelling processes and participation in governance meetings.

Qualifications

• 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 meet internal and external deadlines.
• Two or more years of experience interpreting complex scientific information, assess risks and benefits, draw on insight from multiple sources, and resolve conflicts appropriately
• Two or more years of experience collaborating effectively in cross-functional environments.

Responsibilities

• 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.

Skills

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Policy Advocacy

Regulatory Strategies

Resource Management

Stakeholder Management

Education

Degree in Pharmacy or Life Sciences

Job description

GSK seeks a Manager of Strategic Labelling & Development to lead and maintain Global Datasheets, guiding prescribing information, patient leaflets and labels across markets. You will collaborate with global teams to ensure accurate, science-based labelling reflecting GSK positions during development and early lifecycle stages.

The role emphasizes stakeholder management, regulatory writing and governance, with mentoring of colleagues in labelling processes and participation in governance meetings.