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Job Function:

Legal & Compliance

Job Sub Function:

Health Care Compliance

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

The Senior Manager, Health Care Compliance (HCC), Innovative Medicine R&D – Japan & Korea is the senior compliance adviser and accountable HCC lead for Innovative Medicine Research & Development activities across the two-country cluster. The role provides visible, independent and risk-based leadership that enables ethical, patient-centric and compliant execution of clinical development, External Scientific Innovation and related scientific activities.

Working across two distinct legal, regulatory, industry-code and cultural environments, the position partners with senior R&D leaders and regional and global stakeholders to anticipate, assess and mitigate HCC risks; convert complex requirements into practical decision pathways; strengthen business risk acumen; and sustain effective compliance programmes in both markets. The role also provides leadership beyond the cluster through selected APAC and global initiatives, helping scale consistent approaches, insights and capabilities across the region.

Key Responsibilities

Strategic Compliance Partnership

• Serve as the primary HCC leader and trusted strategic adviser to senior Innovative Medicine R&D leadership in Japan and Korea, with particular focus on Global Clinical Operations and other relevant R&D and innovation functions.
• Set a coherent cluster HCC strategy and annual risk-based priorities aligned with global and APAC objectives while recognising the distinct business, regulatory and cultural context of each market.
• Engage early in business planning, portfolio priorities, clinical-development strategies and external collaborations so that compliance considerations inform decisions before execution.
• Provide clear, constructive challenge and practical advice that enables responsible innovation, smart risk-taking and timely business outcomes.
• Coach leaders and employees to embed Our Credo, ethical judgement, accountability and a culture of integrity into day-to-day decisions.

Risk Assessment and Advisory

• Own the cluster-level HCC risk assessment and mitigation approach, integrating country-specific risks into a clear view of priorities, controls, accountabilities and residual exposure.
• Advise on higher-risk or novel matters involving clinical studies, investigator and site engagement, study equipment, clinical-trial agreements and payments, HCP/HCO and government-official interactions, patient engagement, grants and donations, third parties, scientific and commercial independence, external innovation partnerships and related R&D activities.
• Translate complex requirements into practical guidance and defensible decision pathways; ensure significant or precedent-setting matters are documented and escalated appropriately.
• Drive a proactive lifecycle approach to risk identification, mitigation, monitoring and remediation by embedding HCC considerations into business planning, study governance and operational execution.
• Establish and oversee risk mitigation plans, leading indicators and corrective and preventive actions, ensuring clear ownership, timelines, root-cause analysis and effectiveness checks.
• Monitor changes in the Japan and Korea regulatory, enforcement and industry-code environments and assess their implications for the cluster risk profile and HCC programme.

Compliance Programme Execution

• Lead the design, implementation and continuous improvement of effective HCC programmes for Japan and Korea, including governance, policies and procedures, risk assessment, training and communications, monitoring, third-party risk management, issue management and remediation.
• Apply global standards consistently while tailoring controls and execution to local legal requirements, business models, risk profiles and market maturity.
• Use monitoring outputs, key risk indicators, data analytics, audit and assessment findings, business insights and emerging trends to provide forward-looking advice and prioritise preventive action.
• Oversee sensitive issue response, investigations and remediation within the role’s remit, partnering with appropriate functions and escalating material matters promptly.
• Maintain clear evidence of programme design, implementation, oversight and effectiveness, and provide concise reporting to relevant governance bodies and leadership teams.
• Periodically test whether controls and remediation measures operate as intended and drive sustainable improvement where gaps are identified.

Cross-Functional and Regional Collaboration

• Build strong partnerships with Legal, Quality, Regulatory, Finance, Global Clinical Operations, Clinical & Cross-Functional Solutions, ESI, JLABS and other relevant teams to deliver integrated and practical outcomes.
• Lead effective HCC engagement with key governance and leadership forums in Japan and Korea, ensuring that significant risks, decisions, trends and actions are visible and understood.
• Coordinate with country, APAC and global HCC colleagues to align standards, avoid duplication and leverage specialist capabilities, including monitoring, assessments, third-party due diligence and data analytics.
• Lead or materially contribute to regional and global initiatives such as risk assessment, monitoring, policy enablement, simplification, digital transformation and capability building.
• Share market insights and scalable practices across APAC and act as a regional subject-matter leader where assigned.

People, Culture and Capability Leadership

• Promote integrity, accountability, respectful challenge and ethical, patient-centric decision-making across R&D activities in Japan and Korea.
• Build HCC and business risk capability through coaching, targeted learning, decision tools and practical guidance that support appropriate business ownership within clear guardrails.
• Provide functional leadership to HCC colleagues, contractors or matrix resources supporting the cluster; set priorities, clarify accountabilities, provide feedback and promote high-quality, consistent delivery.
• Where people-management responsibility is assigned, develop and retain talent through regular coaching, performance and career conversations, succession planning and inclusive team practices.
• Champion operational excellence, simplification and digital enablement, using automation and analytics to improve effectiveness, efficiency and stakeholder experience.
• Model a growth mindset and foster collaboration, learning and knowledge sharing across countries and the wider HCC organisation.

Qualifications and Experience

• Bachelor’s degree in law, business, finance, life sciences, data analytics, compliance or a related discipline; an advanced degree or relevant 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 and the ability to assess risks across the clinical-study and external-collaboration lifecycle.
• Demonstrated knowledge of applicable laws, regulations and pharmaceutical industry codes in Japan and Korea, or the ability to rapidly build and apply expertise across both markets.
• Proven success influencing senior stakeholders and translating complex requirements into pragmatic, risk-based solutions in a matrixed multinational environment.
• Experience leading significant programmes, cross-functional initiatives or matrix teams; direct people-management experience is advantageous but not essential.
• Demonstrated ability to use data analytics and digital tools to identify trends, improve risk insight and strengthen programme effectiveness.
• Business-level fluency in Japanese and English is required; Korean-language capability is strongly preferred. Exceptional candidates with fluency in Korean and English and strong demonstrated capability to operate effectively in Japan may also be considered.

Required Capabilities

• Strategic leadership: Sets direction across two markets, connects compliance priorities to business strategy and focuses resources on the most significant risks.
• Integrity and judgement: Demonstrates high ethical standards, independence and the confidence to make and stand by difficult decisions.
• Risk leadership: Anticipates emerging risks, distinguishes material issues from routine activity and develops proportionate, sustainable mitigations.
• Influence and communication: Engages credibly with senior leaders, communicates complex issues clearly and influences outcomes without relying on formal authority.
• Cross-cultural effectiveness: Builds trust and adapts leadership and communication approaches across Japan, Korea and the broader APAC environment.
• Execution and accountability: Manages competing priorities across markets, establishes clear ownership and follows through to measurable outcomes.
• People and capability development: Coaches others, creates development opportunities and raises compliance and risk acumen across the organisation.
• Digital and analytical acumen: Uses data, technology and insights to strengthen decision-making, monitoring and continuous improvement.
• Change leadership: Leads through ambiguity, simplifies ways of working and helps stakeholders adopt new operating models and controls.

Key Relationships

• Japan and Korea Innovative Medicine R&D and Global Clinical Operations leadership
• APAC and global R&D, ESI and HCC leadership
• Legal, Quality, Regulatory, Finance and other assurance and enabling functions
• Clinical Operations, Clinical & Cross-Functional Solutions, JLABS and related R&D and innovation teams
• Country HCC organisations and specialised regional or global compliance teams
• Relevant external stakeholders, where appropriate

 

 

Required Skills:

 

 

Preferred Skills:

Audit Management, Compliance Frameworks, Compliance Management, Confidentiality, Consulting, Corporate Governance, Corrective and Preventive Action (CAPA), Healthcare Industry, Health Care Regulation, Interpersonal Influence, Legal Services, Medical Compliance, Organizing, Process Improvements, Program Management, Technical Credibility