Medical Lead (Established Products) - Final Signatory

ENGINEERINGUK; London; On-site; GBP 60,000 - 100,000

Job description

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.

In this role you will:

• Lead, coach & manage 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.
• Be accountable for clinical/medical activity with impact on regulatory licenses across the EP portfolio. This includes regulatory authority data requests and RTQs, RMTs, labeling 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).

Basic Qualifications & Skills:

• 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:

• Previous clinical or scientific experience in relevant disease areas in the EP portfolio.
• Robust understanding of 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)

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.