Senior Manager, Medical Excellence and Operations
R
Revolution MedicinesBiotech/Pharmaceuticals
Remote (Japan)Full-TimeManager
Salary not disclosed
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Job Details
- Languages
- Japanese, English
- Experience
- Minimum 5 years
- Required Skills
- Compliance
Requirements
- Minimum 5 years of experience in MA or related functions in the pharmaceutical or biotech industry.
- Strong background in Medical Governance, Compliance, Regulatory Affairs, or Medical Operations.
- Deep knowledge of global and local regulatory requirements for MA including MHLW, PMDA, JPMA, ICH, and GVP.
- Experience developing SOPs, Policies, and governance frameworks.
- Experience leading MRC or similar governance structures.
- Fluency in Japanese and English (business level).
- Ability to navigate complex regulatory and legal environments.
- Strong interpersonal, communication, and leadership skills.
Responsibilities
- Develop and implement a comprehensive Medical Governance framework to support strategic and operational excellence.
- Lead contract management activities for MA vendors, consultants, and external partners.
- Oversee execution of MA projects ensuring timely delivery.
- Ensure activities align with MHLW, PMDA, JPMA, ICH, and GVP regulations.
- Contribute to logistical planning and execution of medical congresses and advisory boards.
- Write, review, and monitor regional Medical Review Committees (MRCs).
- Write and implement regional SOPs and work instructions.
- Support digital transformation initiatives and medical systems optimization.
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