Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

As a subject matter expert with solid understanding of global healthcare laws and regulations including FDA fraud and abuse laws, Foreign Corrupt Practices Act (FCPA), the UK Bribery Act and other anti-corruption laws or regulations, industry codes and Company policies, this role will contribute to the achievement of the Compliance department's strategic goals performing a broad range of compliance-related tasks.  This highly motivated individual will oversee the global compliance program, ensuring compliance with international requirements, industry standards and internal policies across multiple jurisdictions and act as a strategic business partner to Ex – U.S. business units providing guidance and oversight to ensure ethical and compliant operations worldwide.

Principle Responsibilities:

• Primarily responsible for oversight of all compliance activities outside of North America
• Monitor changes in global pharmaceutical regulations and standards, and proactively advise and ensure compliance with internal policies and procedures.
• Conduct investigations, audits and risk assessments across international markets and third parties
• Key responsibility is to audit and oversee compliance of Azurity’s vast network of distribution partners.
• • Design training programs to promote a culture of compliance across international locations including third parties
  • Prepare compliance reports for Compliance leadership and the Executive Leadership team providing insights on the state and effectiveness of the global compliance program
  • Manage and respond to compliance related incidents, including hotline calls, and breaches of policies, procedures, and Code of Conduct.
  • Advise US Compliance Leadership Team on global compliance matters.
  • Develop Global controls for ex US and Canada business.
  • Subject Matter Expert (SME) for Foreign Corrupt Practices Act (FCPA) as well as compliance with Anti-Bribery and Anti-Corruption (ABAC) laws
  • Partner with privacy counsel to ensure compliance with privacy laws.Collaborate cross-functionally with departments such as Legal, Medical, Commercial, Quality, Finance, Corp Development and Clinical Operations.

  Qualifications and Education Requirements

  • Bachelor’s degree in related field required
  • 10-15 years of pharmaceutical experience in global compliance, risk management, internal audit, or related fields
  • Management level experience required
  • In-depth knowledge of international pharmaceutical laws, regulations and standards (EU required; APAC, MENA, LATAM beneficial)
  • Strong project management and interpersonal skills
  • Detailed working knowledge and experience with Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, GDPR and ABAC.
  • Excellent written and verbal communications skills
  • Ability to travel internationally as required (up to 30%).
  • Experience working in a matrixed multinational environment.

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