Manager/Associate Director, Labelling Strategy and Development - Open to flexible working
2 days left
- Contract Type
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 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 in the UK based team, 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.
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 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 centralised procedure.
- Management of GRA Labelling data in appropriate systems and databases (primarily Veeva vault).
- 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.
- 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.
- 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.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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.
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.
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