Manager, Labelling Strategy and Development

Descrizione del lavoro:

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, (COMPANY NAME) 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 (COMPANY NAME), 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 the UK, you will help us support our exciting pipeline of new products in the therapy area of Oncology. 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 (COMPANY NAME) products. You will liaise with colleagues in Clinical, Safety, Regulatory and other company 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 (COMPANY NAME) product.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at (COMPANY NAME) on our webpage Life at (COMPANY NAME) | (COMPANY NAME)

In this role you will:
* Lead the development of the Global Datasheet for new oncology products 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 (COMPANY NAME).
* 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 & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Life sciences/pharmacy degree
* 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 & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
* PharmD or higher degree.
* Specific experience with prescribing/patient information.
* 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 work in complex matrix teams. Excellent communication skills.
* Show a focus on improving performance and excellence in all tasks. Challenge ways of working to seek improved process.

Closing Date for Applications -27 Nov 2024 (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.

At (COMPANY NAME), we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Find out more:
Our approach to R&D.

Why (COMPANY NAME)?
Uniting science, technology and talent to get ahead of disease together.

(COMPANY NAME) 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 (COMPANY NAME) a place where people can thrive. We want (COMPANY NAME) 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.

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 neurodiversity, 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@(COMPANY NAME).com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

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
(COMPANY NAME) 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 (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). 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 (COMPANY NAME). (COMPANY NAME) 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, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) 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 (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site