US-MA, Product Medical Lead SR0025613-MZ
Responsibilities % of Time 20% Support development of US medical strategy and plans with alignment with Global Medical Team Work with GMTL and Global Franchise and Product Leads to develop US medical plans that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre- and post- launch setting. Support development of the in-year medical tactical plan and budget for US initiatives and where applicable, collaborate with Global initiatives As delegated by the GMTL functional (e.g. publications, medical communications, medical information and medical training) plans supporting US medical strategy with alignment with Global where applicable. As delegated by the GMTL, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution As delegated by US,GMTL, participate in product development strategy and provide medical affairs and R&D inputs 40 Implementation in-year of US medical strategy with global alignment As delegated by the GMTL and IMM Franchise Head, directly implement plans in the US and collaborate with Global Franchise and Product Leads, potentially including: Development and implementation of medical pre- and post- launch plans for late-stage pipeline products or product label expansions for US Providing medical leadership for scientific communications, including core scientific statements, standard responses, Phase IV plans, and publications Planning, designing and managing or participating in local, regional, national and global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval in RnD select Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process as designated GMTL Managing design and execution of clinical studies (phase IIIb/IV, disease registries, HEOR studies, outcomes surveys, etc.) in close collaboration with Global Franchise and Product Leads, Scientific Affairs, Shared Medical Excellence and Clinical Operations Managing completion of regulatory obligations (e.g. medical affairs input in safety review teams (SRTs). Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements Conducting and ensuring timely medical review and approval of promotional and meeting materials as required per SOP Serving as US Medical representative on standing and project-based cross-functional teams Serving as Global Medical representative on standing and project-based cross-functional teams 30 Effective compliant collaborations with internal stakeholders (R&D, commercial, marketing, regulatory, legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy Act as a company medical representative to engage external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest. Represent Medical Affairs at internal and external meetings Present data on product / disease area at internal and external meetings 10 Maintenance of knowledge base Serve as a key medical resource on the disease area and on specific product Maintain a high level of expertise on the disease area Develop and maintain knowledge of US and International pharmaceutical regulations, guidelines codes of practices and Takeda policies related to all medical activities As directed by the GMTL and Global Franchise,, Product Leads will develop, conduct, or participate in therapeutic training programs for Takeda internal department Education and Experience Requirements A Doctor Degree in Medicine (MD), PhD, or PharmD is required. At least 5 years of related work experience in industry, clinical or research institution, preferably in genetics, metabolic, pulmonary, hematology or AATD related experiences Experience in medical affairs particularly rare disease is preferred Experience in supporting brands or disease area levels in country, regional or global organizations is preferred Experience in other relevant disease areas of interest through clinical experience, biopharmaceutical experience or education may be considered Other Job Requirements Availability to travel domestically and internationally as needed for approximately 20-30% of time Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends
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