Senior Manager, Health Care Compliance, Innovative Medicine R&D – Japan & Korea

About the role

The Senior Manager, Health Care Compliance (HCC), Innovative Medicine R&D serves as the senior compliance adviser and accountable HCC lead for Innovative Medicine research and development across Japan and Korea. The role provides independent, risk-based leadership for ethical, patient-centric and compliant execution of clinical development, external scientific innovation and related scientific activities, working across two different legal, regulatory and cultural environments.

Key responsibilities

• Serve as the primary HCC leader and strategic adviser to senior R&D leadership, setting a coherent cluster strategy and annual risk-based priorities aligned with global and APAC objectives.
• Integrate country-specific risks into risk assessment and mitigation, advise on high-risk matters such as clinical studies, investigator and site engagement, clinical-trial agreements, payments, HCP/HCO and government-official interactions, and patient engagement, grants and donations.
• Drive a proactive lifecycle approach to risk identification, mitigation, monitoring and remediation, and establish risk mitigation plans, leading indicators and corrective and preventive actions.
• Lead the design, implementation and continuous improvement of HCC programmes, including governance, policies, training, monitoring, third-party risk management and issue management, while applying global standards and tailoring to local requirements.
• Monitor regulatory, enforcement and industry-code changes in Japan and Korea, oversee sensitive issue responses and investigations, and report concisely to governance bodies.
• Partner with Legal, Quality, Regulatory, Finance, Global Clinical Operations and other teams, coordinate with country, APAC and global HCC colleagues, and lead regional and global initiatives such as risk assessment, monitoring, policy enablement and digital transformation.
• Coach leaders and employees on ethics and integrity, build HCC and business risk capability, and provide functional leadership to HCC colleagues, contractors or matrix resources.

Required profile

• Bachelor's degree in law, business, finance, life sciences, data analytics, compliance or a related discipline; an advanced degree or professional certification is preferred.
• Typically at least 8 years of relevant experience in compliance, legal, audit, risk management, monitoring, clinical operations or the pharmaceutical or life-sciences sector.
• Strong understanding of R&D and clinical-development activities.