Medical Lead Established Products Final Signatory
Medical Lead Established Products Final Signatory
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Job Description
Medical Lead (Established Products) Final Signatory
GSKs General Medicines therapeutic area is vital to GSK with a portfolio of trusted brands that will impact the lives of 700 million patients in the next decade including the Established Products (EP) portfolio.
This is a role bringing medical expertise that works as an equal partner with Safety Regulatory Quality Supply chain Commercial and Regional/LOC teams and other key external and internal crossfunctional stakeholders to ensure that assets in the established product portfolio continue to be available to meet patient needs.
This is a role driving improved patient and public health outcomes. He/she will require an ability to combine scientific understanding of specific disease areas and knowledge with a practical grasp of patient unmet need physician perspectives treatment landscape priorities and the product safety and regulatory environment.
As a Final Medical Signatory you will play a pivotal role in safeguarding the integrity of our medical content and materials. Working within a dynamic and collaborative environment you will have the opportunity to collaborate with crossfunctional teams to ensure that our communications adhere to regulatory guidelines while effectively conveying the benefits and risks of our products.
Please note that depending on experience this position may be considered at either the G6 or G5 level.
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 inoffice work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK
In this role you will
Lead coach & managing the medical CEP team to help deliver the GSK mission and to ensure achievement of company objectives.
- Ensure colleagues have a robust knowledge of the relevant and emerging clinical evidence supporting their training by partnering on the creation and delivery of highquality scientific materials for both internal and external use
Develop deep subject matter expertise on the products and therapy areas as well as the ability to drive proactive strategic planning
Provide scientific input to Global Product Strategy Digital Fuel Digital Platforms & Data Strategy and Customer Strategy & Engagement teams to support/advise on core claims and material review and cross portfolio content for primary care physicians pharmacists and carers
Be accountable for clinical/medical activity with impact on regulatory licenses across the EP portfolio. This includes regulatory authority data requests and RTQs RMTs labelling discussions including GDS & NCDS reviews and updates and working with R&D technical experts and TCS to address all regular reporting (inc. PBRERS PSURs DSURs) and clinical dossier (inc. rebaselining renewals and PREPs) requirements
Be accountable for fulfilling the clinical and medical requirements of the Medical Device Regulations to ensure physician and patient access to our established medical devices
Uphold the highest compliance standards & provide authoritative opinion on medical and ethical matters to support colleagues across GSK enabling the evidence based use of GSK medicines and compliance with the relevant statutory requirements (e.g. ABPI Code of Practice Medicines Act and EU Directives).
Why you
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
MD/MBBS/PharmD in clinical / scientific discipline preferably related to relevant disease areas in the EP portfolio
Experience working as a nominated Final Signatory or commensurate experience working in copy approval under the ABPI guidelines in the pharmaceutical industry.
Previous clinical or scientific experience in relevant disease areas in the EP portfolio
Considerable experience in Medical Affairs including UK roles
General understanding of statistics safety quality supply chain and regulatory requirements
Strong interpersonal verbal and written communication skills in English
Ability to prioritise and manage multiple projects budgets and interactions simultaneously
Ability to thrive in a fast paced innovative environment while remaining flexible proactive resourceful and efficient
Outstanding listening communication & collaborative team working and leadership skills as the role involves interface with a wide range of stakeholders internally and externally
Evidence of alignment to GSK Values
Preferred Qualifications & Skills:
Please note the following skills are not necessary just preferred if you do not have them please still apply:
Previous clinical or scientific experience in relevant disease areas in the EP portfolio
Robust understanding of l codes of practice and regulations (certification where applicable)
Demonstrated matrix leadership in previous roles with ability to build strong networks manage complexity and cultural diversity
Experience in medical support for briefing documents for regulatory interactions and payor dossiers
Understanding of risk management and quality
Demonstrated experience with developing global or local medical strategies and asset launches especially within a priority market
Skilled at simultaneous consideration of scientific data and practical healthcare delivery needs from diverse health systems to optimise medical delivery
Closing Date for Applications March 30th 2025 (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 GSK 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 techenabled 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. Were uniting science technology and talent to get ahead of disease together.
Find out more:
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 its 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.
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 or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
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 assured Hiring Managers do not have access to this information and we will treat your information confidentially.
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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 GSKs 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at
Employment Type
Full-Time
Key Skills
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