【英語を活かす】コンプライアンスリードジャパン/ Compliance Lead Japan

A global biotechnology company is seeking a Compliance Lead Japan. The selected candidate will ensure adherence to industry regulations, support commercial operations, and drive compliance initiatives. This is a full-remote setup role.

A leading global biotechnology company, it is dedicated to developing innovative and affordable oncology treatments, leveraging cutting-edge research and a strong commitment to patient care. With a growing presence in Japan, it focuses on advancing precision medicine and expanding access to life-changing therapies.

Keywords:

コンプライアンス, 医薬品, 規制遵守, 医療業界, 企業倫理, 法規制, 監査, リスク管理, 医療従事者対応, トレーニングプログラム, 求人, 外資系

Job Ref: 7XAOEI

Responsibilities:

• Develop and maintain the Japan Healthcare Compliance Program in line with industry codes and best practices
• Identify and address legal and regulatory compliance risks, revising policies as needed
• Support compliance in Commercial, Medical, and Clinical Development activities, including HCP fair market value and third-party risk management
• Establish policies and procedures for fraud prevention, privacy, and transparency reporting
• Design and implement compliance training programs for employees and third parties
• Provide compliance oversight for grants, sponsorships, advisory boards, and HCP interactions
• Conduct internal reviews, risk assessments, and audits to identify and mitigate compliance risks
• Manage compliance investigations in collaboration with internal and external stakeholders
• Promote compliance awareness and maintain communication channels for reporting concerns
• Develop and execute an annual Compliance Workplan, including strategic priorities and budgeting

Requirements:

• Bachelor's degree or above in Business, Risk Management, or Law (Advanced degree preferred)
• 8-10 years of pharmaceutical compliance experience in Japan
• Experience in compliance across APAC is a plus
• Deep understanding of Japan's healthcare regulations and industry codes (JPMA, JFTC)
• Ability to influence stakeholders and collaborate across departments
• Proficiency in MS Office Suite
• Ability and willingness to travel
• Native level Japanese; business level English