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

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 ResponsibilitiesStrategic Compliance PartnershipServe 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 AdvisoryOwn 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 ExecutionLead 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 CollaborationBuild 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 LeadershipPromote 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 ExperienceBachelor’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 kno