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Global Healthcare Compliance Director

1 settimana fa

Milano, Lombardia, Italia Recordati A tempo pieno

At Recordati, we are a global pharmaceutical company dedicated to unlocking the full potential of life. Our mission is to develop and commercialise medicines that serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

Job Purpose

The Group Healthcare Compliance Officer will lead the development, implementation, and oversight of the Group's healthcare compliance program. Reporting directly to the Group Compliance and Ethics Officer, this role will provide expert guidance and support to Local/Regional Compliance Officers across various regions, ensuring adherence to applicable international regulations, industry standards, and Group Policies, while fostering a culture of compliance throughout the organization.

Key Responsibilities
  1. Healthcare Compliance Program Development:

    • Develop and maintain a comprehensive global healthcare compliance program that aligns with international regulations and industry best practices, in close collaboration with the Group Compliance and Ethics Officer and Local/Regional Compliance Officers.

    • Develop, review, and update global healthcare compliance policies and guidelines, including those related to interactions with Healthcare Professionals and Healthcare Organizations (HCPs and HCOs), interactions with patient associations, promotional practices, Fair Market Value (FMV), and transparency obligations.

    • Support Local/Regional Compliance Officers in adapting and implementing global compliance standards and controls to meet local regulatory requirements.

    • Develop and disseminate global compliance tools, templates, and resources.
  2. Local/Regional Compliance Officer Support, Global Standards, and Consistency:

    • Ensure consistent application of global healthcare compliance policies and procedures across all regions.

    • Provide expert guidance and support to Local/Regional Compliance Officers on complex healthcare compliance issues, including but not limited to interactions with HCPs and HCOs, promotional practices, FMV, and transparency obligations.

    • Act as a point of contact for Local/Regional Compliance Officers, facilitating communication and knowledge sharing across regions.

    • Assess the effectiveness of local healthcare compliance programs, conducting regular reviews to ensure adherence to global standards, identify potential risks, and provide recommendations for corrective action.

    • Promote cross-country collaboration and knowledge sharing among Local/Regional Compliance Officers to enhance global compliance capabilities.
  3. Training and Education:

    • Develop and deliver a global healthcare compliance training program for employees and (if needed) business partners, ensuring comprehensive understanding of relevant regulations and Group policies.

    • Support Local/Regional Compliance Officers in delivering effective healthcare compliance training programs tailored to local needs.

    • Monitor and evaluate the effectiveness of healthcare compliance training programs, identifying areas for improvement.
  4. Monitoring and Reporting:

    • Develop and implement an adequate healthcare compliance monitoring program.

    • Prepare and present reports to the Group Compliance and Ethics Officer and other senior management on the status of the global healthcare compliance program, including key metrics and recommendations.

    • Perform healthcare compliance reviews and due diligence, when needed.
  5. Risk Management:

    • Identify and assess healthcare compliance risks, developing and implementing mitigation strategies.

    • Monitor and track emerging healthcare compliance risks and regulatory changes, providing guidance to Local/Regional Compliance Officers on how to address them.

    • Support Local/Regional Compliance Officers in identifying and addressing material compliance or reputational risks.
  6. Cross-Functional Collaboration:

    • Collaborate with other departments, such as Legal, Regulatory Affairs, Medical, Finance, Marketing, Sales and Internal Audit, to ensure strategic alignment and consistency in healthcare compliance-related activities.
Required Education

Masters degree in law, business administration, or a related field.

Required Skills and Experience
  1. Minimum of 10 years experience in healthcare compliance, in a global pharmaceutical company.
  2. Strong knowledge and understanding of global healthcare compliance regulations and industry best practices.
  3. Experience in developing and implementing healthcare compliance programs in Europe and/or US.
  4. Excellent communication, interpersonal, and presentation skills.
  5. Ability to work effectively in a global, matrixed organization.
  6. Strong analytical and problem-solving skills.
  7. Strong knowledge of anti-bribery and anti-corruption laws (e.g., FCPA, UK Bribery Act).
Required Languages

Fluency in English is required; fluency in additional languages is a plus.

We are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.