Manager/Senior Manager, Material Review Governance & Operation
BeOne Medicines · Japan
About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
The Manager/Senior Manager, Material Review Governance & Operation, is responsible for the governance, oversight, and enhancing of BeOne Medicines Japan’s 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 of BeOne’s 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.
Qualification Required:
Education Required:
Minimum of B.S. or equivalent education
Master’s Degree is preferred
Supervisory Responsibilities:
- NA
Computer Skills:
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- Veeva PromoMats or similar review platforms
- Document Management Systems (DMS)
- Literature databases (PubMed, Embase)
- Workflow and reporting tools
Other Qualifications and Experiences:
Required
- Bachelor's degree or higher in Pharmacy, Medicine, Life Sciences, or related field.
- Minimum 8+ years of pharmaceutical industry experience.
- Strong knowledge of PMD Act, JPMA Code, and Guideline for Sales Information Provision Activities.
- Demonstrated experience in leading projects working with multi-functional stakeholders in a matrix organization
- Strong analytical skills, sound judgment, and the ability to manage competing priorities in a dynamic environment
- Excellent Japanese written and verbal communication and stakeholder management skills
Desired
- Experience in medical and promotional material review
- Experience in vendor management
- Background in Medical Affairs, Sales & Marketing, Regulatory, and Compliance
- English communication skills, a plus.
Travel:
- NA
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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