11 дней назад
Senior Manager, Health Care Compliance, Innovative Medicine R&D – Japan & Korea
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Health Care Compliance, Innovative Medicine R&D – Japan & Korea (Healthcare Compliance/Clinical R&D): Leading risk-based compliance strategy and programme execution for clinical development and external scientific innovation activities across Japan and Korea with an accent on regulatory interpretation, risk mitigation, and stakeholder partnership. Focus on assessing complex clinical and external-collaboration risks, strengthening controls and monitoring, and translating requirements into practical decision pathways.
Location: Chiyoda, Tokyo, Japan
Company
develops healthcare solutions across Innovative Medicine and MedTech to prevent, treat, and cure complex diseases.
What you will do
- Lead Health Care Compliance strategy and risk-based priorities for Innovative Medicine R&D activities across Japan and Korea.
- Advise senior R&D and Global Clinical Operations leaders on clinical studies, investigator and site engagement, agreements, payments, grants, donations, third parties, and external innovation partnerships.
- Design, implement, and continuously improve compliance programmes covering governance, policies, training, monitoring, third-party risk, issue management, and remediation.
- Oversee risk assessments, mitigation plans, investigations, corrective and preventive actions, effectiveness checks, and compliance reporting.
- Partner with Legal, Quality, Regulatory, Finance, Clinical Operations, ESI, JLABS, APAC, and global compliance teams.
- Coach leaders and HCC colleagues while advancing digital enablement, analytics, operational excellence, and capability building.
Requirements
- Bachelor’s degree in law, business, finance, life sciences, data analytics, compliance, or a related discipline; an advanced degree or professional certification is preferred.
- At least 8 years of relevant experience in compliance, legal, audit, risk management, monitoring, clinical operations, pharmaceuticals, or life sciences.
- Strong understanding of R&D and clinical-development activities and the related external-collaboration lifecycle.
- Knowledge of pharmaceutical laws, regulations, and industry codes in Japan and Korea, or the ability to build expertise across both markets.
- Experience influencing senior stakeholders and leading programmes, cross-functional initiatives, or matrix teams in a multinational environment.
- Business-level Japanese and English are required. Korean capability is strongly preferred.
Nice to have
- Advanced degree or relevant professional certification.
- Direct people-management experience.
- Korean-language capability.
- Experience with data analytics and digital tools for compliance monitoring and risk insight.
Culture & Benefits
- Work in an inclusive environment focused on dignity, diversity, integrity, and accountability.
- Support ethical, patient-centric decision-making across R&D activities.
- Collaborate across Japan, Korea, APAC, and global functions.
- Contribute to regional and global initiatives involving monitoring, policy enablement, simplification, digital transformation, and capability building.
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