Director, Ethics and Compliance

Henry Schein•New York, NY

88d

About The Position

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).

Requirements

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
Broad and unique range of professional skills with an expert understanding of industry practices
Outstanding proficiency with tools, systems, and procedures
Expert planning/organizational skills and techniques
Expert independent decision making, analysis and problem solving skills
Outstanding verbal and written communication skills
Outstanding presentation and public speaking skills
Outstanding interpersonal skills
Outstanding conflict resolution skills and ability to deliver difficult messages
Use skill and influence to develop company objectives and principles and to achieve goals in creative and effective ways
Excellent negotiating skills
Strategic planning skills
Project management, consultative skills and ability to manage a budget
Expert in multiple technical and/or business skills
Ability to cultivate and develop lasting internal and external customer relations
Recognized in the industry as an expert
Strong financial skills
Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience.

Nice To Haves

Master's degree or global equivalent preferred.
May hold two or more industry certifications.

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