Amgen
From Amgen's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
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
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
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
.
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