About this role
Career Category Medical Affairs Job Description Job purpose
• Lead and develop product medical strategy and plan based on product strategy. • Key member in the brand team to develop product strategy with and local commercial team. • Provide Japan position on global/region disease and product related programs. • Provide medical affair consideration on portfolio evaluation and discussion. • Lead the planning and execution of evidence generations, publications and medical events.
Key responsibility
• Partners with the brand team in the development and execution of the Local product(s) lifecycle management plan • Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations • TA and/or product specific Medical training • Ensuring consistency of Medical content and scientific messages across various tools and materials • Visits selected KOL’s and study groups for strategic discussions and protocol development • Develops study protocols for Local Amgen sponsored studies (AST); supports and executes Local study protocol preparation, filing, review and approval in line with • Amgen processes and policies • Works with Global Study Operations (GSO) to ensure preparation, implementation and completion of ASTs • Supports GSO in participation and completion of global/region studies in the country, including provision of input into site selection • Reviews Local ISS proposals prior to approval and ensures appropriate • Local/region/global committee review, if applicable • Oversees in-sourced/out-sourced medical programs and logistics • Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels • Provides Medical expertise for pipeline products • Provides Medical expertise for Health Economy and reimbursement requests
Basic Qualifications Selection Criteria (minimum Qualifications)
• Master’s degree in life-science or relevant area, equivalent education history • Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia • Experience in developing and executing Medical strategy for pre-launch products. • Experience in Medical Department or Clinical Development • Experience with clinical study management and conduct • Knowledge of commercialization and business practices • Fluent in Japanese and English
Preferred Qualifications Preferred Requirements
• MD, PharmD or PhD is strongly preferred • Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs • Therapeutic area knowledge and experience is preferable • Network of customer contacts in therapeutic area • Finance and budgeting experience • Capability of office works and project managements
Competencies
• Medical/scientific expertise, and business acumen • Fluency in English, both oral and written communications • Strong communication and presentation skills • Continuously expanding medical and scientific knowledge as well as • market knowledge • Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management) • Strong customer orientation; science-based • Ability to work in a cross-functional team (e.g., Commercial, Clin Development, EU teams, HE, Regulatory, Safety, etc.) • Role model for others in line with Amgen Values • Demonstrates leadership skills
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