Senior Manager / Manager - Global Medical Affairs - Early Vaccines

Rockville, MD
September 27 2021
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Site Name: USA - Maryland - Rockville Posted Date: Sep 27 2021 Are you interested in a medical affairs role that leverages your project management expertise to accelerate global medical affairs engagement? If so, this Senior Manager Global Medical Affairs role could be an ideal opportunity to explore. As a Senior Manager Global Medical Affairs, you will provide Medical Affairs expertise, scientific evidence, access focus and insights from external stakeholders to cross-functional teams within the organisation. Ensure optimal evidence generation strategies are in place for assigned assets in early pipeline, to enable successful development, registration, access, and overall launch readiness. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Under the supervision of the Global Medical Affairs Portfolio Lead (GMPL), executes the Global Medical Affairs Plan (MAP) for the relevant asset(s)/ indication(s). Drives delivery of designated elements of the MAP. Contributes to the medical affairs section of the integrated asset plan (IAP) and Integrated Evidence Plan (IEP) in alignment with global medical accountabilities e.g. disease landscape, external engagement plans etc. Develops and implements agreed elements of External Expert Engagement Plans in alignment with Scientific Engagement principles and relevant GSK policies; external activities could include Advisory boards, External Medical round tables, HCP scientific meetings. Drives excellence in scientific engagement with key stakeholders (External Experts, HCPs, Patients, Payers and Regulators) and maintains excellent professional relationships. Sound medical voice of GSK, able to represent the medical affairs team externally according to the level of experience and subject matter. Gathers medical insights and builds a deep understanding of external stakeholders' needs to inform and shape the asset's development programme. Provides medical/ scientific insights and leadership to cross-functional teams working on assigned assets, to validate assumptions and recommendations during the technical and commercial review process. Brings expertise to strategic discussions regarding the evidence requirements by leveraging an understanding of anticipated changes in disease landscape, treatment paradigm and evolution of Policy/Payor scenarios in key LOCs to optimise data generation and life-cycle management plans globally. Assists in identifying and generating medical, epidemiological, clinical and health economic outcomes and research data to create value and ensure proactive engagement with key internal and external stakeholders to ensure integration and alignment of data/ activities in line with customer and patient needs.Contributes to the interpretation of the data to provide medical input to asset development, scientific communication and commercial strategy and materials Provides expert knowledge of data and literature related to the asset(s)/project(s); identifies important publications for communication to medical network and project team, prepares position papers, rebuttals, feed-back on literature selection Critically appraises, reviews and recommends changes to publications, commercial and clinical documents for alignment to strategy, clarity of messages and scientific accuracy. Ensures that plans and activities are implemented in a manner that is compliant with Scientific Engagement principles, GSK's Code of Practice and GSK values and that all communications (internal and external) are scientifically accurate, balanced, aligned with asset strategy, and compliant to applicable laws and regulations. Under the supervision of the GMPL, contributes to the medical communication strategy for the assigned areas of work, including long term communication / publication planning. Co-develops and implements integrated scientific medical communication plan, Works in collaboration with medical operations team and manages agency partners as required depending on services and activities being provided. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Medical Doctor, PharmD, PhD in life sciences. Specialization in vaccinology, immunology, infectious diseases, microbiology, virology, life sciences, public health, health economic policy is preferred. At least 5 years industry and/or clinical experience in the relevant field, acquired through global or regional/Local Medical Affairs or non-Medical Affairs relevant functional areas: e.g. regulatory affairs, clinical, epidemiology, market access, discovery etc. Preferred Qualifications: If you have the following characteristics, it would be a plus: Business acumen acquired through work with non-Medical Affairs relevant functional areas (Commercial, Governmental Affairs, Market Access) Knowledge and understanding of the drug/ vaccine development process from asset inception through lifecycle management. Strong analytical skills to be able to assess and interpret scientific data and ability to develop, design and implement Phase 2 & 3b /4 studies. Experience in product launch, life cycle management or early development Demonstrated ability in engaging, building and sustaining a broad and strong external (expert) network. Clear understanding of the ethical, regulatory, compliance and legal framework which underpins all of GSK's interactions with the external environment; knowledge of the issues that face Pharma Industry with respect to interactions with External Experts Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment. Experienced speaker on scientific/medical topics in fora of different audiences, including Advisory boards, public panel discussion. Proficient in managing multiple projects, budgets, and matrix interactions (internal / external consistent with each research project). Strong analytical skills to be able to assess and interpret scientific data Ability to independently develop and review new materials based on strategy, core evidence documents and communication strategy, publication experience Ability to take a solid fact-based position Experience with review & approval processes in a highly regulated setting Experience of managing external vendors Why GSK? 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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