Career Category

Medical Affairs

Job Description

Job purpose

• Lead and develop product medical strategy and plan based on product strategy.
• Key member to develop product strategy and LCM with brand team.
• Provide China 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.

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  AST’s (Amgen sponsored studies); 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 ​
• Oversees 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​

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Basic Qualifications Selection Criteria (minimum Qualifications)

• Master degree
• 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 Chinese (Mandarin) and English

Preferred Qualifications Preferred Requirements

• MD, PharmD or PhD is required
• 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 ​
• Network of customer contacts in therapeutic area​
• 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, Clin Development, EU teams, HE, Regulatory, Safety, etc.)​
• Role model for others in line with Amgen Values​
• Demonstrates leadership skills​

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