Amgen

Medical Advisor (BONE)

Japan · Work style not stated · Full time

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About the role

Description from the employer’s posting. Check the employer’s page for the current version.

Medical Affairs

Career Category: Medical

Report to: CMAL

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

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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 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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