London, Tokyo, United Kingdom
14 hours ago
Medical Lead (Established Products) – Final Signatory
Site Name: UK – London – New Oxford Street Posted Date: Jan 21 2025 Medical Lead (Established Products) – Final Signatory GSK’s 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 cross-functional 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 cross-functional 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 in-office 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 high-quality 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 Provide strategic oversight for the low carbon Ventolin launch in the UK. 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 – February 9th, 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 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 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, it’s 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. 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