The Opportunity:

We are seeking a highly motivated and experienced professional to join our team as a Medical Excellence and Operation (ME&O). Reporting to the Head of Japan Medical Affairs, this role will establish and oversee governance frameworks, including regional Medical Review Committees (MRCs), Standard Operating Procedures (SOPs), and cross-functional medical governance initiatives. ME&O will be responsible for managing contracting, vendor oversight, and project execution in close partnership with Global Medical Affairs (GMA) and regional stakeholders. The ideal candidate will have expertise in medical governance, compliance, and regulatory frameworks with the  biotech/pharmaceutical industry.Key Responsibilities:

• Develop and implement a comprehensive Medical Governance framework to support strategic and operational excellence across Regional and GMA.

• Lead contract management activities, including negotiation, execution, and tracking for MA vendors, consultants, and external partners.

• Oversee execution of MA projects and initiatives, ensuring timely delivery and alignment with business priorities.

• Work closely with Legal, Compliance, Regulatory, and Finance teams to ensure MA operations align with company policies and external regulations.

• Ensure medical activities align with corporate policies and external regulatory guidance, including MHLW, PMDA, JPMA, ICH, GVP, and other relevant regulations.

• Contribute to logistical planning and execution of medical congresses in partnership with internal stakeholders, ensuring seamless coordination of medical presence, booth activities, and KOL engagements.

• Support the planning and execution of advisory boards, symposia, and other key medical events, including contracting, compliance oversight, and logistics management.

• Drive continuous improvement efforts to streamline governance frameworks and enhance efficiency with MA Operations.

• Write, review, and monitor regional MRC, ensuring efficient and compliant medical review of materials, communications, and scientific content.

• Write, implement, and monitor regional SOPs, work instructions, and best practices to drive consistency and compliance.

• Support digital transformation initiatives within MA, including the implementation and optimization of medical systems, databases, and reporting tools.

Required Skills, Experience and Education:

• 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 MedicalOperations.

• Deep knowledge of global and local regulatory requirements for MA, including MHLW, PMDA, JPMA, ICH, GVP, and industry best practices.

• Experience developing SOPs, Policies, and governance frameworks to support medical organizations.

• Experience leading MRC or similar governance structures.

• Fluency in Japanese and English (business level).

• Ability to navigate complex regulatory and legal environments and advise teams on best governance practices.

• Strong interpersonal, communication, and leadership skills with the ability to influence cross functional stakeholders.

Preferred Skills:

• Advanced scientific or medical degrees (MD, RPh, PhD) preferred; MS or equivalent experience in biomedical sciences or business management field considered.

• Experience working in global biotech/pharmaceutical environments, supporting multiple departments or teams.

• Expertise in digital platforms for compliance tracking, document management, and governance reporting.

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