Director of Compliance Operations
Director of Compliance Operations
Director of Compliance in Heatlhcare
About Our Client
A fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe.
We are currently hiring for a Director of Compliance Operations for our Mt. Laurel, NJ office.
Responsibilities include but are not limited to:
- Develop and maintain a comprehensive Compliance Program modeled after the standards recommended by the Office of Inspector General and the Federal Sentencing Guidelines, for an early US approval medical device company.
- Draft, revise, promulgate and maintin policies and procedures to prevent, detect, and resolve instances of non-compliance related to federal and state law, industry standards, and company policies.
- Develop applicable corporate-wide compliance training and be the primary educator for company-wide and functional compliance training.
- Develop a compliance monitoring and audit program that is used to build internal controls, mitigate risk, and correct issues.
- Identify potential areas of compliance vulnerability and risk, develop and implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
- Establish a Company-wide compliance operating committee to drive compliance initiatives and ensure tone is set at the top.
- Ensure compliance with HIPAA, GDPR, and other privacy regulations.
- Establish a marketing review protocol to ensure materials are within FDA requirements and within labelling.
- Establish multiple layers of compliance reporting of good faith complaints, including use of a compliance reporting hotline.
- Serve as functional matter expert on Anti-kickback and Off Label Issues for the organization.
- Provide consistent and timely guidance on compliance questions and issues that come up within the organization, with particular emphasis on the sales and marketing functions.
- Serve as a key advisor on appropriate structuring and modeling of customer contracts with a particular focus on anti-kickback safeguards.
- Develop contract compliance internal controls.
- Design consultant agreement process to ensure legitimate need, FMV and other considerations are accounted for within the negotiation and drafting of HCP consulting agreements.
- Work with Marketing and Professional Education on developing all HCP related training and educational/marketing programs.
- Strategize and help design state and federal transparency reporting tracking of HCP expenses.
- Serve as reviewer and approver of state and federal transparency submissions.
- Be a recognized leader in the Legal and Compliance field.
- Help guide on complex healthcare economics modeling and practices and work with the head of Reimbursement on coverage strategies.
- Provide guidance on appropriate safeguards around compliance in the area of clinical studies.
- Develop and track metrics, benchmarks and success criteria to measure the efficiency and effectiveness of the various programs and processes.
- Leverage the Compliance function as a competitive advantage for the company
The Successful Applicant
- Juris doctorate with one active license in any US jurisdiction.
- Master's degree in Public Health or Business Administration a plus.
- 10 years of Healthcare Compliance experience with at least 5 years in medical device.
- Direct experience dealing with healthcare economics issues and/or coverage determinations.
- Expert understanding of fraud and abuse, anti-kickback, and off label issues as they relate to activities within a fast-paced medical device company.
- Excellent analytical, strategic thinking and problem-solving skills. Ability to define and employ quantitative/statistical assessment approaches.
- Excellent verbal and written communication skills.
- Effective team player who is also capable of working independently with strong self-motivation.
- Ability to identify and address issues quickly and with precision.
What's on Offer
Competitive Compensation and package