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Henry Schein

Director, Compliance - Orthopedics

Remote

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, antitrust, data protection and privacy, conflicts of interest, transparency, advertising and promotion of medical devices

  • Collaborate with Commercial and Medical Affairs 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 (code of conduct), interactions with healthcare professionals, labeling and promotional content

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  • 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
  • Assure applicable annual 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 preferred) 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 (March 2023), 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 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

    MINIMUM WORK EXPERIENCE:

    Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience.

    PREFERRED EDUCATION:

    Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent preferred. May hold two or more industry certifications.

    TRAVEL / PHYSICAL DEMANDS:

    Travel typically less than 20%. Office environment. No special physical demands required.

    The posted range for this position is $137,600- $216,720 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.

    This position is eligible for a bonus not reflected in the posted range.

    Other benefits available include: Medical, Dental, and Vision Coverage, 401K Plan with Company Match, Time off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program, and Volunteer Opportunities

    Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

    For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

    Job ID: Henry_Schein-R125754
    Employment Type: Full Time