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About the Role

Lead and develop product medical strategy and plan based on product strategy. Serve as a key member of the brand team to develop product strategy with the local commercial team. Provide Japan's position on global/region disease and product-related programs. Offer medical affairs considerations for portfolio evaluation and discussion. Lead the planning and execution of evidence generation, publications, and medical events.

Responsibilities

Partner with the brand team in the development and execution of the local product lifecycle management plan.
Lead and develop the local medical strategy and medical activities for the product(s) in accordance with internal and external regulations.
Provide TA and/or product-specific medical training.
Ensure consistency of medical content and scientific messages across various tools and materials.
Visit selected KOLs and study groups for strategic discussions and protocol development.
Develop study protocols for Local Amgen sponsored studies (AST); support and execute local study protocol preparation, filing, review, and approval in line with Amgen processes and policies.
Work with Global Study Operations (GSO) to ensure preparation, implementation, and completion of ASTs.
Support GSO in participation and completion of global/region studies in the country, including providing input into site selection.
Review Local ISS proposals prior to approval and ensure appropriate local/region/global committee review, if applicable.
Oversee in-sourced/out-sourced medical programs and logistics.
Participate in/conduct Local Advisory Board Meetings, Investigator Meetings, and/or Expert Panels.
Provide medical expertise for pipeline products.
Provide medical expertise for Health Economy and reimbursement requests.

Requirements

Master’s degree in life-science or relevant area, equivalent education history.
Minimum of 2 years in the pharmaceutical industry, or proven industry collaboration in academia.
Experience in Medical Affairs Department or Clinical Development.
Experience with clinical study management and conduct.
Knowledge of commercialization and business practices.
Fluent in Japanese and English.

Skills

Medical/scientific expertise
Business acumen
Strong communication skills
Strong presentation skills
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
Leadership skills

Location

Japan

Work Type

Full-time

Experience Level

Minimum of 2 years

Education Level

Master’s degree
MD
PharmD
PhD

About the Company

Amgen Values