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Kyowa Kirin International plc
,
Galashiels, Roxburgh, Ettrick and Lauderdale
Head of Medical EMBU
Overview
Job Description
Job Purpose Develop and lead EMEA Medical Affairs strategic planning and operational execution in the KKI Established Medicines Portfolio, in order to create, optimize, and maintain excellence in scientific engagement between Kyowa Kirin International (KKI) and all relevant stakeholders. Key Responsibilities: Medical Affairs Expertise in Established Medicines portfolio. Develop the EMEA Medical Strategy for the EMBU portfolio during ongoing lifecycle-driven revisions with key responsibilities to include: * Leadership of KKI medical interests with alliance (commercialisation) partners * Responsibility for providing input into labelling process and negotiation to optimize transparency of Benefit: Risk profile and applicability of label to clinical practice * Responsibility to support payer/market access strategy * Validation of proposed promotional claims for the brand as supported by the label * Collaboration with the commercial team to inform the marketing and sales strategy, and responsibility for the review and approval of core central marketing and promotional materials * Ensuring consistency of approach between regions (US/EU/Asia) and representation of affiliates' Medical Affairs needs * Driving applicable publication planning of ongoing trials * Develop and deliver the medical communications strategy as the medical expert within KKI for all products in the EMBU portfolio. * Develop and lead External Scientific Engagement activities, patient advocacy and, more generally, scientific organization strategy and activity planning (ensuring affiliates needs are considered and connected) * Define and/or lead congress activity, disease-based education, and product based education for internal and external stakeholders * Develop and deliver the publication plan partnering as required to support evidence generation and dissemination * As the Medical Head of the EMBU oversee development of responses to medical information requests and be accountable for accuracy of standard responses for the portfolio. * Represent the affiliate companies and be the liaison into regulatory, QA and pharmacovigilance discussions and documentation in the maintenance of all TA marketed products, including review and certification of commercial and regulatory documents (i.e. labelling, benefit-risk statements, etc) * Provide ethical and compliant leadership, through knowledge of regulations and visible behaviour that reinforces these values * Attend as necessary meetings with regulatory authorities or other agencies. Principles: This role will function as the Medical Affairs lead across KKI for the EMBU portfolio and is responsible for leading and coordinating all therapeutically-aligned medical activities. An effective partnership with the commercial leader will be essential for success as will partnership with other stakeholders. This role will take guidance from the EVP Medical Affairs EMEA for governance and compliance purposes to ensure consistency of approach across business units and to optimize overall externally-facing medical activities within KKI. The medical and commercial leads will need to build strong partnerships with affiliate colleagues. As this role will have direct reports leadership/people management ability is essential. Position Requirements * Minimum 10 years industry experience, ideally with previous experience in an Established Medicines portfolio * Proven broad Medical Affairs experience in the EU * Strong background in Medical Affairs * Able to demonstrate working successfully at an international level * Relevant scientific degree or appropriate certification, with medical qualification preferred * Broad understanding of healthcare delivery environment, and the role of thepharmaceutical industry within it * Comprehensive understanding of Industry medical and financial governance norms, with particular reference to compliance with all laws, regulations, and codes of scientific and promotional Practice * In-depth knowledge of relevant disease areas (preferred) * Interpretation and communication of scientific data in clear language Skills and Capabilities * Global Team experience desirable with demonstrated ability to add significant value andto influence the medical strategy for brands with the cross functional teams * Proven ability to influence stakeholders * Effective collaboration across cross-functional and geographical boundaries * Proven track record of delivering value added medical offerings * Effective spoken and written communication across multiple media including presentations, teleconference, meetings etc.