Compliance Business Partner Cordis North America

RESPONSIBILITIES AND ACCOUNTABILITES

  • Perform autonomous compliance monitoring of business unit activities, healthcare related events, activities and conferences, and interactions with Healthcare Professionals (“HCPs”), Healthcare Organizations (“HCOs”), Non-Clinical Stakeholders, and Governmental Officials, both locally and outside the U.S. and Canada business units
  • Manage the review and approval of all activities that require compliance pre-approval before payment and ensure process transparency, documentation completeness and proper archiving
  • Deliver, monitor, and ensure the availability of applicable compliance policies and procedures to the business and any necessary third parties
  • Support the North American Compliance Manager with training the different business unit operational and corporate business segments on compliance policies and procedures, industry code, and any applicable laws, as well as identifying, developing, and drafting new or revised policies or procedures, both for employees and third parties, when applicable
  • Support the legal entities to be compliant with the local and international anti-corruption laws
  • Support investigations within the Cordis U.S. & Canada business units where compliance concerns are raised or policy or procedure violations occur
  • Ensure compliance with regulations and compliance controls by examining and analyzing Cordis U.S. and Canada business unit records, reports, operating practices, and documentation
  • Continually analyze the compliance program delivered to the Cordis U.S. & Canada business units and, when appropriate, recommend opportunities to strengthen the deliverables, program, or structure
  • Support the Cordis U.S. & Canada business units in the due diligence process on third-party intermediaries, if necessary
  • Support the Cordis U.S. & Canada business units in applicable HIPAA or other local country privacy compliance or education
  • Participate, in the capacity of compliance member, as may be needed, in functional committee meetings
  • Participate in U.S. or Global projects when requested
  • Coordinate and participate, when necessary, in the audit of accounting and other records for the purpose of compliance audits with focus on key compliance risk areas, including: payments to HCPs and fair market value; payment to non-clinical stakeholders and government officials in general; local medical events and conferences; educational grants, commercial sponsorships, and charitable donations; fees to hospitals; transactions with HCOs and medical associations; distributor and third-party intermediary due diligence; employee expense reports

QUALIFICATIONS

  • Either: (1) at least 3 years of experience in healthcare regulatory law or healthcare compliance specifically relating to fraud, waste & abuse/ anti-bribery and open payments/ transparency law in the U.S. & Canada within any of the medical device, pharma, or provider services industries; or (2) the ability to demonstrate a working knowledge of healthcare compliance specifically relating to fraud, waste & abuse/ anti-bribery and open payments/ transparency law in the U.S. & Canada within the medical device industry through (i) the ability to identify, understand and practically apply the laws and regulations governing medical device distributors and manufacturers; and (ii) a practical working knowledge of relevant industry code
  • Working knowledge of the U.S. Foreign Corrupt Practices Act and Canada’s Corruption of Foreign Public Officials Act
  • Experience creating and providing relevant, practical training materials/ sessions, both live and via a learning e-system
  • Ability to demonstrate an aptitude to facilitate the needs of the business or operational segment of the organization while working within legal and compliance parameters
  • Experience monitoring the business and operational segments of an organization for compliance with business standards, rules, policy, industry and legal regulatory requirements, and, if necessary undertaking corrective action(s)
  • CHC certified is a plus but not required
  • Practical working knowledge of performing audits and investigations
  • Prefer experience working for internationally scoped medical device or pharma manufacturer or distributor, or professional medical services provider
  • Ability to travel up to 15% annually