Manager/Director, Labelling Strategy and Development, Open to flexible working & homeworking
- 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/Director in the UK based team, you will help us support our exciting pipeline of new products. These are global roles and you will be providing labelling support to colleagues in markets worldwide. This may include work on the European SPC, US PI, 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 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
CLOSING DATE for applications: 22/06/2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
- Life sciences degree
- Higher degree: PhD, PharmD
- Track record of authoring clear scientific labelling text for health professionals and patients
- Specific experience with prescribing/patient information
- 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
- 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
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
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.
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.
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.