• Masters, PharmD or PhD in life sciences
• Knowledge of the Pharmaceutical and/or Vaccine Industry; broad understanding of the different disciplines involved, with a sound knowledge of life sciences & vaccination: vaccines, infectious diseases, immunology, preventive medicine and public health.
• 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
• Local affiliate experience (LOC) is considered as an asset
• Speciality in immunology, infectious medicine, epidemiology or other relevant specialty is considered an asset
• Scientific and medical knowledge/expertise in designated disease/product area acquired through education, readings, daily work, attendance to meetings (internal and/or external), and attendance to congresses.
• Basic knowledge of budget and account management
• English fluent. (French useful if Belgium-based). Other international languages are an asset.
• Proficient in using a PC and common software packages (Word, Excel, Powerpoint).
• Medical Doctor preferred
• 6+ years recognized experience and expertise in medical affairs and teamwork. Ideally includes experience managing external experts and interacting with EE's and organising activities involving EEs
• Experience in Influzena arena
Senior Manager Global Medical Affairs - Seasonal Influenza - Philadelphia (USA)
GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Italy, Belgium and China.
Our Vaccines business is one of the largest in the world, producing paediatric and adult vaccines against a range of infectious diseases. In 2013, we distributed more than 860 million doses to 170 countries, of which over 80% were supplied to developing countries.
At GSK Vaccines, we employ over 12,000 people worldwide, including more than 8,000 at our global headquarters in Belgium. Almost a quarter of our staff work in research and clinical development, inventing new and innovative vaccines against some of the world's most serious infections and diseases.
For more information please visit www.gsk.com
Support/leads the development and implementation of the Global Medical Affairs Strategies supporting the launch optimization of the seasonal influenza vaccines: Fluarix™ and Flulaval™ quadrivalent/tetra vaccines in the identified key countries, and prepare the launch of the new 6-months indication in US and international by providing Medical expertise, market access focus and insights to cross-functional teams within the organisation.
Knowledge and application of the GSK Code of Practice, Scientific Engagement and applicable Policies and SOPs in all areas of Medical Affairs.
• Under the supervision of the Global Medical Affairs Leader (GMAL), constructs Medical Plans (MPs) , building input from global gap analyses, Region, key LOCs (Local operating companies) input, and stakeholder and customer input (external and internal)
• Ensures integration and alignment of relevant global, regional and local Clinical, Epidemiology and Health Outcome activities and provides medical support / advice in collaboration with the GMAL to these plans
• Ensure integration and alignment with the MP(s) with the Business Plan(s)
• Participates and provides medical input to various meetings including: Scientific Evidence and Access Stream(s), Vaccine Commercialization Team (VCT) streams, Vaccine Development Teams, Internal medical training/ updates, Commercial meetings, DI meeting/activities... Can also lead VCT streams
• Contributes to the interpretation of the clinical / R&D / H-E / Epi data to provide medical input to development, scientific communication and commercial strategy and materials
• Drives harmonisation of key wordings / vocabulary used (e.g. on safety) across different projects.
• Under the supervision of the GMAL , drives the medical communication strategy for the product(s) including long term communication / publication planning
• Co-development and implementation of the integrated medical communication plan (ISCP), (as a Key responsibility), including medical leadership of the secondary publication plan
• Ensures that medical/ scientific communications are scientifically sound and aligned with strategy from a medical perspective
• Critically appraises, review and recommends changes to publications, commercial and clinical documents for alignment to strategy, clarity of messages and scientific accuracy.
• Agrees the execution of the External Expert Engagement Plan within the MP and implements the activities assigned in alignment with Scientific Engagement principles and relevant GSK policies and principles; external activities could include Advisory boards, External Speakers Programmes, Medical education, Medical round tables, HCP meetings
• Sound medical voice of GSK, able to represent the medical affairs team externally according to the level of experience and allocated product(s)
• Demonstrates professional and ethical attitudes in External Experts (EEs) interaction and in EE development activities
• Contributes actively to the success of congresses by fulfilling identified roles, including interpreting scientific information related to the field of responsibility, active contribution in delivering the congress report, active representation of GSK and of the product at the congress and pre-symposia planning activities. Presentation of GSK data during GSK satellite congress symposia or scientific sessions.
• Implements (may lead the implementation through others) the agreed elements of the EE Plans, works in collaboration with the medical operations team, Regional and LOC medical teams, VCT and involving all stakeholders to define strategic needs.
• Builds and maintains excellent professional relationships with External Experts in full respect of Scientific Engagement Principles.
• Manage agency partners, including setting agency brief, as appropriate - this activity may be managed in part by Medical Operation Managers directly, depending on the service being provided and who is driving the content.
• Provides medical insights and leadership to cross-functional teams working on the assigned GSK product(s).
• Develops internal training material under supervision of the GMAL but with increasing independence and provides medical training at internal meetings for the relevant product(s) and therapy area(s) to GSK Regional/ LOC medical teams
• Expert knowledge of data and literature related to the product/project(s); identification of important publications for communication to medical network and project team, preparation of position papers, rebuttals, feed-back on literature selection
• Actively contributes to the development of Medical Affairs processes and harmonisation activities
• Accountable for providing medical advice to commercial partners in the development of Key Claims and promotional material, ensuring in particular, balanced and proportional content, appropriately referenced, and aligned with product strategy.
• Conducts medical review and approval of promotional material in line with the Code of Practice and other relevant SOPs.
• Under guidance of the GMAL, provides medical input in the construction, writing and review of medical/ clinical data summaries for Tender Dossiers.
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