Medical Advisor (BONE)

Job description

Career Category Medical Affairs

Job Description

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

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 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 .