Medical Advisor
1112 amgen k k
📍 japan - tokyo japan🕐 1mo ago🔗 workday
Job Description
**Career Category**
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Medical Affairs
**Job Description**
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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
.