Insulet Corporation

  • Healthcare Compliance Counsel

    Job Locations US-MA-Acton | US-MA-Billerica
    Posted Date 2 months ago(10/4/2018 8:07 AM)
    Category
    Legal
  • Position Summary

    The Healthcare Compliance Counsel/Professional will join our Legal Department and function as a key member of the team supporting the development, implementation and maintenance of a compliance program to promote understanding and compliance with applicable laws, regulations, industry standards and Company policies and procedures affecting medical device sales, marketing, R&D/clinical efforts and reimbursement.  Compliance-related areas include, but are not limited to, interactions with health care professionals and end-user customers, federal and state false claims, anti-kickback and anti-inducement laws and regulations, clinical research, HIPAA data security, North American transparency reporting, Medicare Part D and pharmacy pricing/formulary matters, and compliance program monitoring, auditing and training.

    Responsibilities

    Responsibilities:

    • Assist in the development, implementation and maintenance of the Company’s overall compliance strategy, compliance program and annual compliance work plan.
    • Perform and document risk assessments and develop, implement and maintain policies, procedures and controls to address risk areas.
    • Develop, implement and deliver appropriate and effective compliance communication and training programs.
    • Provide subject matter expertise and guidance to business units in the areas of interactions with health care professionals and end-user customers, federal and state false claims, anti-kickback and anti-inducement laws and regulations, clinical research compliance, HIPAA data security, North American transparency reporting, Medicare Part D and pharmacy pricing/formulary matters and other compliance issues.
    • Conduct internal compliance monitoring and auditing of identified risk areas.
    • Develop and apply tools and metrics to track and assess Company compliance with policies and procedures and the overall effectiveness of the compliance program.
    • Provide reports, on a regular basis or as directed by the General Counsel, to keep the Compliance Committee and appropriate members of senior leadership informed of the operation and progress of the compliance program.
    • Maintain current knowledge of the applicable federal, state, local and international laws, regulations, licensing requirements, industry standards and related trends affecting corporate compliance activities and make necessary modifications to the compliance program and related policies and procedures.
    • Conduct, manage and resolve compliance investigations and implement corrective actions and remedial measures.
    • Performs other duties as required.

    Education and Experience

    Education and Experience:

     

    Minimum Requirements:

    • BA Degree
    • Minimum of 5 years’ experience developing and implementing compliance programs in the health care industry, preferably with a medical device company.
    • Strong working knowledge of the legal and regulatory framework affecting the medical device industry domestically and internationally including Medicare and Medicaid; federal and state anti-kickback, anti-inducement, false claims and transparency reporting laws and regulations; HIPAA data security; the AdvaMed Code; standards established by CMS and DHHS-OIG for effective compliance programs; and international laws and regulations affecting patient data security, interactions with health care professionals and transparency reporting.
    • Familiarity with financial, FDA quality/regulatory and human resources operations within a public medical device company

     

    Preferred  Skills/Competencies:    

    • JD Degree preferred
    • Excellent interpersonal and communication skills including the ability to communicate complex legal and regulatory issues effectively across the organization.
    • Certification in Health Care Compliance optimal.
    • Ability to influence, build trust, work independently and collaboratively, and develop positive relationships at all levels of the company.
    • Ability to investigate highly confidential organizational issues and apply integrity and good judgment to the process.
    • Strong problem resolution skills and ability to multitask, prioritize and respond to emerging issues effectively in a challenging, fast-paced environment.

    Physical Requirements:

    • None

     

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