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About the Role

The Senior Manager, Health Care Compliance (HCC) serves as the senior compliance adviser and accountable HCC lead for Innovative Medicine Research & Development activities across Japan and Korea. This role provides leadership to enable ethical, patient-centric, and compliant execution of clinical development and related scientific activities, while partnering with senior R&D leaders to mitigate HCC risks and strengthen compliance programs.

Responsibilities

Serve as the primary HCC leader and trusted strategic adviser to senior Innovative Medicine R&D leadership in Japan and Korea.
Set a coherent cluster HCC strategy and annual risk-based priorities aligned with global and APAC objectives.
Engage early in business planning, portfolio priorities, clinical-development strategies and external collaborations so that compliance considerations inform decisions.
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.
Own the cluster-level HCC risk assessment and mitigation approach.
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.
Drive a proactive lifecycle approach to risk identification, mitigation, monitoring and remediation.
Establish and oversee risk mitigation plans, leading indicators and corrective and preventive actions.
Monitor changes in the Japan and Korea regulatory, enforcement and industry-code environments and assess their implications.
Lead the design, implementation and continuous improvement of effective HCC programmes for Japan and Korea.
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.
Oversee sensitive issue response, investigations and remediation within the role’s remit.
Maintain clear evidence of programme design, implementation, oversight and effectiveness, and provide concise reporting.
Periodically test whether controls and remediation measures operate as intended and drive sustainable improvement.
Build strong partnerships with Legal, Quality, Regulatory, Finance, Global Clinical Operations, Clinical & Cross-Functional Solutions, ESI, JLABS and other relevant teams.
Lead effective HCC engagement with key governance and leadership forums in Japan and Korea.
Coordinate with country, APAC and global HCC colleagues to align standards, avoid duplication and leverage specialist capabilities.
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.
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.
Provide functional leadership to HCC colleagues, contractors or matrix resources supporting the cluster.
Where people-management responsibility is assigned, develop and retain talent.
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.

Requirements

Bachelor’s degree in law, business, finance, life sciences, data analytics, compliance or a related discipline.
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.
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.

Skills

Strategic leadership
Integrity and judgement
Risk leadership
Influence and communication
Cross-cultural effectiveness
Execution and accountability
People and capability development
Digital and analytical acumen
Change leadership
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

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

Senior Manager
8+ years of relevant experience

Education Level

Bachelor's degree in law, business, finance, life sciences, data analytics, compliance or a related discipline
Advanced degree or relevant professional certification is preferred

About the Company

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.