Job Details

Compliance Counsel

Company name

Exact Sciences Corporation

Organization Type

In-House

Job Type

Attorney

Valid Through

Nov 26,2019

Posted on

Aug 13,2019

Years of Experience

Min 6 yrs required

Location

Madison, WI, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Government and Government Relations >> Government and Government Relations
Apply for this job
 
Your Email:
Upload Resume:

 
3 hits

Profile

Compliance Counsel
Duties: 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.

Qualification and Experience

Qualifications: JD 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. 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. Preferred: 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.

Company info

Hiring Coordinator
Exact Sciences Corporation
441 Charmany Drive
Madison, WI 53719