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Healthcare Compliance Director

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Published:   2024/06/20

Type

Full time

Industry

Medical Device

Category

Legal

Salary

¥ 16,000,000 Yearly ~ ¥ 22,000,000 Yearly negotiable

Required language

English: Fluent

Location

Tokyo

Visa

Visa Required

Description

Position Title: Healthcare Compliance Director

Overview: The Healthcare Compliance Director plays a pivotal role in ensuring that the organization maintains the highest standards of integrity and compliance with healthcare laws and regulations. This individual leads the compliance program, fosters a culture of ethical behavior, and provides strategic guidance to senior management and staff.

Key Responsibilities:

  1. Compliance Program Leadership:

    • Develops, implements, and oversees the organization's healthcare compliance program.
    • Ensures compliance with all applicable healthcare laws, regulations, and industry standards, including anti-corruption laws and the Foreign Corrupt Practices Act (FCPA).
    • Regularly reviews and updates compliance policies and procedures to reflect changes in laws and regulations.
  2. Strategic Partnership:

    • Acts as a strategic business partner to executive leadership, providing expert advice on compliance matters.
    • Collaborates with senior management to integrate compliance considerations into business strategies and operations.
    • Advises on ethical decision-making and promotes patient-centric practices.
  3. Risk Management:

    • Identifies, assesses, and manages compliance risks associated with healthcare operations.
    • Develops and implements risk mitigation strategies to prevent non-compliance and minimize legal exposure.
    • Conducts regular risk assessments and compliance audits.
  4. Training and Education:

    • Designs and delivers comprehensive compliance training programs for employees at all levels.
    • Ensures that staff are knowledgeable about compliance requirements and ethical standards.
    • Provides ongoing education and updates on new regulations and industry best practices.
  5. Monitoring and Reporting:

    • Establishes and maintains effective monitoring and reporting systems to track compliance activities and outcomes.
    • Investigates and resolves compliance issues and breaches, ensuring appropriate corrective actions are taken.
    • Prepares regular reports on compliance program effectiveness for senior management and regulatory bodies.
  6. Leadership and Team Management:

    • Leads, mentors, and develops the compliance team, fostering a culture of excellence and integrity.
    • Manages the compliance department's budget, resources, and performance.
    • Builds and maintains a strong network of compliance professionals and industry contacts.
  7. Stakeholder Engagement:

    • Engages with external stakeholders, including regulatory authorities, industry associations, and healthcare professionals.
    • Represents the organization in compliance-related discussions and initiatives.

Requirements

Qualifications:

  • Education:

    • Minimum of a Bachelor’s degree in business, law, healthcare administration, or a related field. An advanced degree (MBA, JD, or equivalent) is preferred.
  • Experience:

    • At least 10 years of experience in healthcare compliance, legal, or a related field.
    • Proven track record of developing and leading high-performing compliance programs and teams.
    • Extensive knowledge of healthcare laws, regulations, and industry standards, including the FCPA and anti-corruption laws.
  • Skills:

    • Strong leadership and management abilities.
    • Excellent analytical, organizational, and communication skills.
    • Ability to influence and collaborate with senior management and staff.
    • High ethical standards and a commitment to fostering a culture of compliance and integrity.
    • Proficiency in English; additional language skills are an asset.

Internal Contacts:

  • Senior Business Unit leaders, Sales, Marketing, Legal, Finance, Medical Affairs, Regulatory, and other relevant departments.

External Contacts:

  • Regulatory authorities, industry associations, healthcare professionals, and compliance networks.

Travel:

  • Occasional travel may be required (approximately 10%).

This job description outlines the key responsibilities and qualifications for the Healthcare Compliance Director position, emphasizing the role’s importance in maintaining compliance and ethical standards within the organization.

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