GSK
Manager, Strategic Labelling and Development
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job 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.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
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.
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
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
Compensation
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.
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.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
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.
Accommodation
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
Equal Opportunity Employer
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.
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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
US Transparency Requirements
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/.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location