Labelling Strategy and Development Manager

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 an opportunity in its Global Regulatory Affairs (GRA) Labelling Strategy and Development 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 and vaccines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring these products are correctly prescribed and used is essential, and that’s where our labelling team is key. The Labelling Strategy and Development team supports our portfolio of medicines and vaccines 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 Strategy and Development Manager based in either Belgium, Italy, or the UK, you will help us support our exciting pipeline of new products.  This includes primarily work on the Global Datasheet as well as the European SmPC and Package Leaflet. As this is a global role, you will also provide labelling support to colleagues in markets worldwide.

Our Labelling Strategy and 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, Patient Leaflets and Packaging Components 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 of the Global Datasheet for new vaccines or product line extensions.

• Develop prescribing and patient information for EU markets.

• Manage core and local prescribing/patient information through development and for newly approved products.

• Work with colleagues in markets worldwide to ensure implementation of the Global Datasheet into local prescribing/patient information.

• Author responses to regulatory questions on prescribing/patient information from Regulatory Authorities.

• Author documentation to support Labelling Governance Committees.

• Interface with key labelling and governance stakeholders across GSK.

• Manage documentation to support global and country/regional product information development and early maintenance.

• Author and manage EU product information annexes for products registered via the EU centralized procedure.

• Manage GRA Labelling data in appropriate systems and databases (primarily Veeva vault).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Life sciences/pharmacy degree (or PhD).

• Relevant labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic area experience. Broad experience in regulatory affairs, ideally in labelling activities

• Track record of authoring clear scientific labelling text for health professionals and patients.

• Fluency in English

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PharmD or higher degree.

• Proven leadership skills.

• Experience in managing senior stakeholders to meet internal and external deadlines.

• Proactively seeks information, guidance, and insight from a broad range of sources and weigh benefits and risks before making important decisions.

• Demonstrated high attention to detail and accuracy.

• Ability to recognize and resolve conflicts.

• Ability to work in complex matrix teams.

• Excellent communication skills.

• Specific experience with prescribing/patient information.  

• Understand company priorities and respond appropriately with flexibility to ensure deadlines are met successfully.

• Show a focus on improving performance and excellence in all tasks.

• Challenge ways of working to seek improved process.

• Ability to make sound decisions.

#LI-Hybrid

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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