EMEA Compliance Officer

3 weeks ago

Dublin, Dublin City, Ireland Parexel Full time
When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The EMEA Compliance Manager focuses on the day-to-day operations of the compliance program and is responsible for ensuring adherence to applicable corporate compliance laws, regulations, and industry codes and Parexel policies in the EMEA region. This position will be responsible for developing, implementing, managing, and tracking the company's compliance program initiatives to create and sustain best practice systems, tools, and processes to mitigate corporate compliance risks.

The EMEA Regional Compliance Manager will serve as the local Compliance representative for clients and employees in the EMEA region.

Key Accountabilities
  1. Develop, implement, monitor and track Parexel's global compliance program in the region.
  2. Manage Compliance initiatives to create and sustain best practice systems, tools, and processes to mitigate corporate compliance risks.
  3. Provide in-region expertise and advice on compliance matters and advise management on compliance program needs across the EMEA region.
  4. Serve as the primary liaison with key internal stakeholders in the EMEA region.
  5. Identify existing and potential corporate compliance risks in the EMEA region.
  6. Collaborate with Regional Compliance Officers and key internal stakeholders to develop, strengthen, and implement corporate compliance policies, procedures, and controls to mitigate and respond to risks.
  7. Provide guidance and best practices for interactions with Healthcare Professionals and Government Officials.
  8. Participate in third party due diligence procedures including due diligence of principal investigators and qualification of vendors.
  9. Review of vendor master agreements for corporate compliance terms and conditions.
  10. Monitor employee compliance training completion across the EMEA region.
  11. Deliver training within the EMEA region.
  12. Collaborate with the Regional Compliance Officers in developing key compliance communications including the promotion of our Speak Up Program, Code of Conduct, Compliance Policies, and industry Codes.
  13. Support corporate compliance audits conducted by customers, regulatory authorities, and Parexel's Quality and Internal Audit teams.
  14. Participate in evaluating the root cause of audit findings and development and implementation of corrective actions and mitigation strategies.
  15. Understand healthcare compliance and anti-bribery/anti-corruption issues within EMEA; Consult with Legal & Risk Management as needed.
  16. Track, monitor, and communicate proposed, new, and upcoming healthcare compliance legislation and enforcement issues affecting the healthcare industry in EMEA.
  17. Conduct and manage investigations of suspected violations of Company policies and/or applicable laws and regulations.
  18. Work closely with others in related departments, including HR, Finance, Legal and Risk Management, Quality, and Clinical Operations on corporate compliance issues.
Skills
  1. Excellent interpersonal, verbal and written communication and presentation skills.
  2. Strong analytical skills and attention to detail.
  3. Solid understanding of industry corporate compliance regulations, with a focus on the EMEA region.
  4. Skills to deliver training to a geographically dispersed audience.
  5. Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel.
  6. Client & quality focused approach to work.
  7. Excellent project management and organizational skills.
  8. Ability to quickly learn various project-related systems, their integration points, and related processes.
  9. Knowledge of EMEA corporate compliance processes.
  10. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload effectively.
  11. Ability to work independently.
  12. Willingness to work in a matrix environment and to value the importance of teamwork.
Knowledge and Experience
  1. English proficiency (written and oral English).
  2. A minimum of 3-5 years' experience in a global life sciences/healthcare organization.
  3. Relevant experience in the Clinical Research field (pharmaceutical industry or CRO) or other relevant experience is desirable.
  4. Experience of Quality Management Systems, GXP practices as applied to life sciences industry, including GCP (Good Clinical Practice) is beneficial.
  5. Experience participating in and supporting an Anti-Bribery Anti-Corruption compliance program.
  6. Working understanding of the US Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery/anti-corruption legislation local to the region.
  7. Familiarity with compliance, operational, financial, and quality assurance procedures and regulations.
Education
  1. Bachelor's degree (legal, biological science or other health-related discipline preferred) or equivalent qualification desired.
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