Director, Ethics and Compliance

JOB OVERVIEW:

The Director, Ethics & Compliance position will report to the Chief Ethics & Compliance Officer and will be primarily responsible for overseeing and improving the Ethics & Compliance program for the Henry Schein Products Group (HSPG).  The Director, Ethics & Compliance will provide advice and counsel on compliance with various legal and regulatory requirements applicable to the manufacturing, sales & marketing operations of HSPG globally and will provide advice on and support for the strategic plan.

The Director, Ethics & Compliance, will collaborate with internal clients at all levels of management as well as the corporate Ethics & Compliance team; the role requires the ability to work confidently, proactively, and assertively with a high level of independence. The position requires an individual who can work in new subject matter areas on a daily basis and who can assimilate information quickly and develop expertise in those areas. 

Duties include providing counseling on healthcare compliance issues; working closely with the Chief Ethics & Compliance Officer and the Henry Schein Ethics & Compliance team on strategic compliance matters; providing support on the general compliance needs of the HSPG business unit ; collaborating with key stakeholders to develop, review and/or deliver compliance learning and communications for internal and external audiences; developing and executing auditing and monitoring plans; supporting remediation and risk mitigation efforts, conducting or supporting internal investigations (as needed).

KEY RESPONSIBILITIES: 

• Oversee and evolve the ethics & compliance function and collaborate with key stakeholders to ensure compliance with applicable laws and regulations covering topics such as anti-kickback statute, global anti-bribery/anti-corruption (ABAC), antitrust, data protection and privacy, conflicts of interest, transparency, interactions with healthcare professionals and entities including fee-for-service engagements, third party risk management, advertising and promotion of medical devices, sponsorships, grants, donations, samples.
• Collaborate with Commercial team members to create solutions for developing and maintaining compliant relationships with healthcare professionals and government officials
• Provide compliance training on a wide range of issues including Worldwide Business Standards (our code of conduct), interactions with healthcare professionals, conflicts of interest, ABAC, labeling and promotional content
• Together with the Chief Ethics & Compliance Officer and other key stakeholders, develop and implement a monitoring and auditing program designed to ensure compliance with internal policies and procedures and applicable laws, regulations and industry guidance and standards
• Review new product offerings to ensure compliance with applicable policies and procedures and laws
• Manage outside counsel as necessary
• Support the implementation of the ethics & compliance risk assessment and mitigation actions as well as monthly compliance reports and executive risk dashboard
• Ensure applicable annual transparency reporting requirements are met (state, federal and international)
• Interpret and disseminate information on regulatory and compliance matters
• Assist with internal investigations, business partner and government inquiries and actions, and related responses and resolution
• Enhance corporate compliance and organization reputation by accepting ownership for accomplishing new and different requests, providing prompt and accurate advice and appropriate solution recommendations, and identifying continuous improvement opportunities
• Perform other duties as assigned or as necessity dictates

SPECIFIC KNOWLEDGE & SKILLS: 

• Experience with healthcare law compliance for a global medical device manufacturer (orthopedic medical devices a plus) and experience leading a team or key initiatives
• Strong knowledge of HHS-OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers (including 7+ elements of an effective compliance program), AdvaMed Code, DOJ’s Evaluation of Corporate Compliance Programs (September 2024), False Claims Act, Anti-kickback Statute, anti-bribery/anti-corruption laws (e.g., FCPA, UK Bribery Act), data protection laws (e.g., GDPR, CCPA), Sunshine Act and other transparency laws.
• Experience working with Commercial teams
• Strong understanding of compliance controls, processes and activities common to the medical device industry
• Strong understanding of healthcare compliance and enforcement environment

GENERAL SKILLS & COMPETENCIES: 

• Broad and unique range of professional skills with an expert