Manager, Labelling Strategy and Development

☞ GSK

Aussicht: 170

Update Tag: 16-11-2025

Ort: Wavre Walloon Brabant

Kategorie: Recht / Verträge Planung / Projekte Beratung / Kundenservice

Industrie: Pharmaceutical Manufacturing

Jobtyp: Full-time

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Jobinhalt

Site Name: UK - London - Brentford, Belgium-Wavre, Italy - Siena, Wavre

Posted Date: Jul 4 2022

Manager/Associate Director, Labelling Strategy and 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 Manager 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 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 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 Company Core Datasheet, which contains information for prescribers and patients.

As a Labelling Manager/Associate Director 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 Company Core Datasheet as well as the European SmPC and PL. Because it is a global role, we also provide labelling support to colleagues in markets worldwide.

Our labelling development team supports a product during development and throughout its early lifecycle, and we are the authors of Company Core Datasheets for GSK pharmaceutical 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, active ingredient or device.

These Responsibilities Include Some Of The Following

This role will provide YOU the opportunity to lead key activities to progress YOUR career.
  • Lead the development of the Company Core Datasheet for new medicines or product line extensions.
  • Development of 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 company core datasheet into local prescribing/patient information.
  • Author responses to regulatory questions on prescribing/patient information from Regulatory Authorities.
  • Author documentation to support Labelling Committee.
  • Interface with key labelling and governance stakeholders across GSK.
  • Manage documentation to support global and country/regional product information (PI) development and early maintenance.
  • Author and manage EU PI annexes for products registered via the EU mutual recognition, decentralised, and centralised procedure.
  • Management of GRA Labelling data in appropriate systems and databases (primarily Veeva vault).
Closing Date for Applications: 18/07/22 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

About You

Core competencies:
  • Demonstrated high attention to detail and accuracy.
  • Ability to recognize and resolve conflicts.
  • Ability to work in complex matrix teams.
  • Excellent communication skills.
  • Challenges and questions ways of working to seek improved process.
  • Ability to make sound decisions.
  • Proactively seek information, guidance and insight from a broad range of sources and weigh benefits and risks before making important decisions.
  • Proven leadership skills.
Why you?

Basic Qualifications
  • Life sciences degree.
  • Track record of authoring clear scientific labelling text for health professionals and patients.
  • Relevant Labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic area experience.
  • Experience in managing senior stakeholders to meet internal and external deadlines.
Preferred Qualifications
  • Higher degree: PhD, PharmD.
  • Specific experience with prescribing/patient information.
  • Demonstrates an understanding of company priorities and responds appropriately with flexibility to ensure deadlines are met successfully.
  • Shows a focus on improving performance and excellence in all tasks.
Why GSK?

At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health.

With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years.

All of this depends on our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

R&D

R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. That’s why we’re increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world’s leading consumer genetics and research

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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.

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 GSK’s Transparency Reporting For the Record site.
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Frist: 31-12-2025

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