Senior Manager, Health Care Compliance – R&D, Japan & Korea (Global Pharmaceutical Company)

The senior compliance adviser and accountable health care compliance lead for pharmaceutical R&D across a two-country cluster (Japan and Korea) at a global pharmaceutical company. The role provides visible, independent and risk-based leadership that enables ethical, patient-centric and compliant clinical development and related scientific activities.

• Serve as the primary compliance leader and trusted strategic adviser to senior R&D leadership in Japan and Korea
• Set the cluster compliance strategy and annual risk-based priorities, and own the cluster-level risk assessment and mitigation approach
• Advise on higher-risk matters such as clinical studies, investigator and site engagement, HCP/HCO and government-official interactions, grants and donations, third parties and external partnerships
• Lead the design and continuous improvement of compliance programs: governance, policies, training, monitoring, third-party risk, issue management and remediation
• Partner with Legal, Quality, Regulatory, Finance and Clinical Operations, and coordinate with regional and global compliance colleagues
• Provide functional leadership to compliance colleagues and contractors, and contribute to selected regional and global initiatives

Full-time, Tokyo-based, hybrid work.

• Bachelor’s degree in law, business, finance, life sciences, data analytics, compliance or a related discipline; advanced degree or professional certification preferred
• Typically 8+ years of experience in compliance, legal, audit, risk management, monitoring, clinical operations or the pharmaceutical / life-sciences sector
• Strong understanding of R&D and clinical-development activities, and knowledge of Japan and Korea regulations and pharmaceutical industry codes (or the ability to build it quickly)
• Proven success influencing senior stakeholders in a matrixed multinational environment; experience leading programs or cross-functional teams
• Ability to use data analytics and digital tools to improve risk insight
• Business-level fluency in Japanese and English required; Korean strongly preferred