Career Category Medical Affairs Job Description Job purpose
• Lead and develop product medical strategy and plan based on product strategy.
• Key member to develop product strategy and local commercial team with brand team.
• Provide Japan position on global/region disease and product related programs.
• Provide medical affair consideration on portfolio evaluation and discussion.
• Lead evidence generation and publication plan and execution.
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 GSO to ensure preparation, implementation and completion of AST’s
• Supports GSO in participation and completion of global/region studies in the country
• Reviews Local ISS proposals prior to approval and ensures appropriate Local/region/global committee review, if applicable
• Provides input into site selection for AST’s
• Overseas in-sourced/outsourced 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
• Develops manuscripts and publication materials
• Plans and delivers medical education programs and scientific events
Basic Qualifications Selection Criteria (minimum Qualifications)
• Master’s degree
• Minimum of 3 years in pharmaceutical industry, or proven industry collaboration in academia
• Experience in Medical Affairs 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 required
l 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 l Work experience in oncology area, especially in solid tumour l Network of customer contacts in therapeutic area l Finance and budgeting experience
Competencies
• Medical and scientific expertise
• 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, Research & Development, Regulatory, Safety, etc.)
• Role model for others in line with Amgen Values
Demonstrates leadersh
.