• Compliance Counsel

    Job Locations US-WI-Madison
    Req No.
    2019-4012
    Category
    Human Resources, Legal & Organization Engineering
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Compliance Counsel will have various responsibilities for effectively and efficiently executing a compliance program that meets or exceeds legal and regulatory expectations. This position will work with leadership throughout Company, with a primary focus on the Cologuard® business, for the purpose of continually enhancing the Company’s efforts to ensure compliance with health care industry laws and standards through the development and delivery of real-time guidance and counsel, policies/procedures, internal messaging and training content, and written agreements and external-facing materials that enable achievement of the Company’s mission and financial goals without compromise of its Core Values. The Compliance Counsel will be responsible for directing the following transactional compliance efforts of Exact Sciences Corp.: advising leadership and project teams on the implications of legal risks and industry best practices for commercial strategies, tactics and programs; leading the development of procedures and substantive responses for real-time inquiries from personnel within the commercial organization; providing health and privacy law expertise on engagements involving health care providers/institutions and/or patient information and other data exchange and usage issues; and enhancing the organization’s efforts to create and deliver effective training, education and internal communications supporting the Company’s efforts to identify and address matters of concern.

     

    This opportunity will report to the Vice President and Chief Compliance Counsel of Exact Sciences Corp.

    Essential Duties and Responsibilities

    • Prioritize and provide timely response to questions and concerns raised by sales representatives and other commercial organization representatives during the course of their efforts, ranging from strategic advance-planning to day-to-day matters.
    • Analyze, draft and negotiate terms and conditions of written agreements with third parties that implicate risks particular to the health care industry, including prohibitions on fraud, waste and abuse, as well as protected health information protections and data privacy requirements.
    • Actively contribute to and drive the annual regulatory compliance review and other regular compliance assessments across the business and implement risk mitigation plans.
    • Help ensure that the compliance program is run in a manner comporting with laws, regulations and industry standards that include, among other topics, state and federal anti-kickback statutes, compliance with FDA, CMS and relevant regulatory requirements, and compliance with applicable corporate codes and policies (e.g., the Company’s Code of Conduct on Interactions with Health Care Professionals, which is based on the AdvaMed Code of Ethics on Interactions with Health Care Professionals).
    • Liaise with leadership to implement, develop, and maintain policies and procedures for the general operation of the compliance program and its related activities to prevent illegal, unethical, or improper conduct.
    • Monitor and analyze new and developing laws, regulations and enforcement activity within the health care industry and incorporate learnings into internal education, messaging and policy development efforts.
    • Effectively work with the Chief Compliance Counsel and other internal legal counsel and compliance personnel on legal/compliance policy decisions, procedures and investigations.
    • Identify potential weaknesses in the Compliance Program and proactively suggest improvements to address them.
    • Collaborate with other internal organizations (e.g., Finance, Human Resources, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution.
    • Develop and deliver appropriate training under the Compliance Program.
    • Analyze philanthropic proposals and third-party requests for financial support to ensure prospective appropriateness and internal segregation of duties in consideration of same.
    • Support the process of medical, legal and regulatory review of external-facing materials related to Cologuard.
    • Consult and/or serve on corporate compliance and/or grant committees.
    • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
    • Support and comply with the company’s Quality Management System policies and procedures.
    • Regular and reliable attendance.
    • Ability to work designated schedule.
    • Ability to work nights and/or weekends.
    • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
    • Ability and means to travel between Madison locations.
    • Ability to travel 33% of working time away from work location, may include overnight/weekend travel.

    Qualifications

    Minimum Qualifications

    • Juris Doctor (J.D.) degree.
    • Must hold and maintain an active license to practice law.
    • 6+ years of experience in the Legal/Compliance function of a for-profit company in the healthcare, pharmaceutical, medical device, life sciences and/or clinical laboratory industries; or equivalent experience in private practice advising such companies.
    • Authorization to work in the United States without sponsorship.
    • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

     

    Preferred Qualifications

    • Experience in a Senior Counsel capacity (or its equivalent) for a for-profit company in the healthcare, pharmaceutical, medical device, life sciences and/or clinical laboratory industries; or experience in private practice advising such companies.
    • Experience working in this capacity for a publicly traded entity.

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    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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