Manager/Senior Manager, Material Review Governance & Operation at BeOne Medicines

Job description

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 ma