Manager, Strategic Labelling and Development

GSK; Waltham (MA); On-site; USD 139,000 - 231,000; Full time

Job summary

GSK is seeking a Manager of Strategic Labelling & Development in the US to lead development, authoring and maintenance of Global Datasheets for medicines. You will coordinate with clinical, safety and regulatory teams to ensure accurate prescribing information and patient leaflets across US and international markets.

The role involves liaising with global markets to implement datasheets, managing local labelling differences, and mentoring colleagues in labelling processes within a dynamic,

Qualifications

• Degree in Pharmacy, Life Sciences, Biomedical Sciences or related discipline.
• Experience with stakeholder management and collaboration in complex matrix teams.
• Two or more years interpreting complex scientific information and resolving conflicts.
• Two or more years collaborating in cross-functional environments.

Responsibilities

• Lead development, authoring and maintenance of Global Datasheets for medicines, ensuring labelling reflects GSK’s medical position.
• Manage local prescribing and patient information across stages including US PI, EU SmPC, patient leaflets and labels.
• Collaborate with global markets to implement Global Datasheets across country/regional information and align country labelling differences.
• Author regulatory responses and documentation for Regulatory Authorities and Labelling Governance Committees.
• Interface with labelling, regulatory, clinical, safety and governance stakeholders to align strategy and decision-making.
• Maintain labelling documentation in systems (e.g., Veeva Vault) and mentor colleagues in labelling processes.

Skills

Regulatory leadership

Labelling

Stakeholder management

Cross-functional collaboration

Regulatory compliance

Policy advocacy

Education

Degree in Pharmacy, Life Sciences, Biomedical Sciences

Job description

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 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.
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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 written and verbal English communication skills with a focus on clarity and accuracy.
• 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.

Discover more about our company-wide benefits and life at GSK on our webpage Life at GSK | GSK

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.