【Job Description】
General Description:
The Manager/Senior Manager, Material Review Governance & Operation, is responsible for the governance, oversight, and enhancing promotional and medical material review processes to ensure compliance with applicable regulations, industry codes, company policies, and scientific standards. Reporting to the Director of Medical Operations Japan, in the Medical Affairs organization, this position is the cornerstone Medical-Legal-Regulatory (MLR) review framework and is accountable for maintaining robust governance for promotional and medical material review processes. The role oversees first-level, outsourced reviewers, evaluates and manages their performance, signs off on the reviewed materials for use, as well as resolving conflicts as they arise working with multi-functional stakeholders, such as Medical Affairs, Legal, Regulatory Affairs, Compliance, and  business stakeholders to ensure compliant and effective dissemination of product and disease-related information.
The position also is a critical part of the Promotional Material Review Supervisory Function and serves as secretariat to the Promotional Material Review Oversight Committee, ensuring appropriate risk management, decision-making, documentation, and continuous process improvement across review operations.

【Essential Functions of the Job:】

MLR Review and Promotional Material Governance

Lead and oversee the medical review and approval of promotional and medical materials, ensuring scientific accuracy, medical appropriateness, and compliance with applicable regulations, industry codes, and company policies.

Second-level review a broad range of materials including promotional campaigns, speaker presentations, congress materials, digital content, websites, patient support programs, and marketing communications.

Evaluate promotional claims, supporting references, and scientific evidence to ensure compliant and balanced communication.

Assess and mitigate medical, regulatory, legal, compliance, and reputational risks associated with promotional activities.

Lead MLR review discussions and provide strategic recommendations to support compliant business decision-making.

Vendor Management and Oversight

Manage outsourced Medical Review and Promotional Material Review activities through effective vendor governance and performance oversight.

Establish quality standards, service level agreements (SLAs), and key performance indicators (KPIs) to ensure consistent review quality and operational excellence.

Monitor vendor performance, conduct business reviews, and implement corrective and preventive actions (CAPA) when necessary.

Lead vendor onboarding, training, qualification, and continuous capability development.

Ensure consistent application of review standards and compliance requirements across internal and external review teams.

Promotional Review Operations Management

Lead end-to-end promotional review operations and workflow management to ensure timely, efficient, and compliant material approvals.

Develop, implement, and continuously improve review processes, governance procedures, SOPs, and operational standards.

Maintain appropriate review documentation, approval records, and governance tracking systems.

Drive operational excellence initiatives focused on quality, efficiency, consistency, and compliance.

Governance Committee Facilitation

Serve as the primary liaison between review functions, governance stakeholders, and Promotional Material Review Supervisory Departments.

Facilitate Promotional Material Review Oversight Committee meetings, including agenda management, documentation, action tracking, and follow-up activities.

Present compliance metrics, risk assessments, operational performance, and governance updates to senior leadership and governance committees.

Support escalation and resolution of high-risk issues while ensuring appropriate governance decisions are documented and implemented.