We are seeking a dynamic and experienced compliance professional to drive and advance our healthcare compliance program. This role ensures adherence to laws, regulations, and industry standards while fostering a culture of integrity and ethical business practices. You will work cross-functionally to enhance program effectiveness, mitigate risk, and align compliance initiatives with business objectives. What will I do?
- Lead the development and continuous enhancement of a risk-based, effective compliance program aligned with U.S. Department of Justice (DOJ) guidance and industry best practices.
- Establish, update, and enforce compliance policies, procedures, and self-help tools to support business activities while adhering to regulations such as the Anti-Kickback Statute, False Claims Act, and Foreign Corrupt Practices Act (FCPA).
- Develop and implement training programs and ongoing communication strategies to strengthen compliance awareness and reinforce a culture of compliance.
- Oversee federal and state transparency reporting requirements (e.g., Sunshine Act) to ensure accurate and timely disclosure of transfers of value.
- Implement and manage compliance monitoring programs, analyzing trends, identifying risk areas, and making strategic recommendations for continuous improvement.
- Support the Global Chief Compliance Officer in maintaining the Compliance Committee and integrating anti-bribery/anti-corruption programs.
- Collaborate with Legal, Commercial, Medical Affairs, Market Access, R&D, and other teams to embed compliance into daily operations.
- Conduct compliance risk assessments, manage the annual compliance work plan, and develop risk mitigation strategies.
- Supervise and mentor Compliance Operations team members, fostering collaboration, growth, and business partnership.
How will I get there?
- Bachelor's degree required
- 12+ years of healthcare compliance experience in pharmaceuticals, biotechnology, or medical devices, with in-house global healthcare experience strongly preferred.
- Expertise in designing, implementing, and overseeing key elements of an effective compliance program, including risk assessments, monitoring, and compliance technology systems.
- Strong ability to assess complex compliance risks and develop practical, business-friendly solutions that align with industry regulations and company objectives.
- Experience managing compliance investigations, enforcement matters, and advising senior executives and employees on a broad range of compliance and legal issues.
- Demonstrated ability to build strong partnerships and collaborate across business functions and all levels of the organization.
- Excellent leadership, communication, analytical, and problem-solving skills, with a proven track record in driving compliance initiatives.
- Strong presentation, organizational, and project management skills, capable of handling multiple high-priority projects simultaneously.
- Team-oriented approach to work, fostering a culture of development, collaboration, and ethical business practices.
- Preferred: Juris Doctorate and/or certifications such as Certified in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), or Seton Hall Healthcare Compliance Certification.
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