Compliance Program Manager-Auditing And Transparency

Company Description

Treace's mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers' expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

The Compliance Program Manager role leads and conducts auditing and monitoring for the company. This person will develop and execute auditing and monitoring plans and tactics to evaluate Treace Medical Concepts, Inc.'s (TMCI) adherence to U.S. laws and regulations and company Policies and Procedures. As a member of TMCI's Legal and Compliance Department, this role will be expected to use technology, analytics, and traditional live monitoring to help identify and appropriately remediate potential Compliance concerns. This role will also be responsible for identifying and recommending updates and improvements to TMCI' Compliance Policies and Procedures. This role will also work closely with the Chief Ethics and Compliance Officer and be responsible for performing forensic investigations and other ad-hoc assessments that arise.

This role will also have responsibility for managing TMCI's compliance with the Federal Open Payments Program/Sunshine Act, state laws and restrictions, transparency, and public disclosure requirements. In this capacity, this individual will work closely with Internal Audit, Information Technology, Accounting, Finance and will interact daily with the aggregate spend team, various functions, and external vendors who provide data related to aggregate spend reporting.

PRIMARY DUTIES & RESPONSIBILITIES:

The Manager performs the following with minimal to moderate supervision from the Sr. Director, Legal and Compliance:

• Develop and lead an effective and repeatable risk-based audit and monitoring process across TMCI business activities to evaluate TMCI's adherence to U.S. laws and regulations, industry codes (e.g. AdvaMed Code of Ethics), and TMCI policies and procedures. This includes the development of the audit objectives, scope and audit program for each area reviewed.

• Develop testing methodologies to evaluate the adequacy of the design and effectiveness of internal controls.

• Partner with colleagues and key stakeholders to report on the effectiveness of management controls on a regular basis.

• Assist Sr. Director and CLCO with the annual risk assessment process by identifying, evaluating and prioritizing risk areas, based on prior monitoring observations as well as existing and emerging risk areas.

• Recommend appropriate process improvements, enhancements to existing policies and controls, and issue remediation plans to stakeholders and management.

• Partners with all levels of key business functions to provide moderately complex OEC and policy interpretation and requirements, trend analysis and best practice recommendations.

• Incorporate monitoring observations and trends into compliance policies, processes, training and communications.

• Develop appropriate analytics and use technology to track monitoring metrics, trends and observations and to expand and advance monitoring capabilities.

• Develop and deliver relevant training to internal stakeholders and third parties

• Assist in TMCI compliance obligations including, but not limited to, the collection and reporting of required information and data for federal and state law and regulations, including reports required under the Open Payments Program and state law monitoring and reporting requirements.

• Develop and deliver Open Payments/Transparency related communications, training, and work tool development to support the TMCI's Open Payments Program and State Transparency adherence.

• Assist aggregate spend internal or external resources with business and technical projects associated with data collection, reporting, and monitoring.

• Work on Compliance-related projects associated with the development of new business processes and implementation of technical solutions to comply with the Physician Payments Sunshine Act and state regulations.

• Keep abreast of changes to laws and regulations related to TMCI's business.

• Produces professional quality reports and provides input for presentations to the Board of Directors, and correspondence with a high level of accuracy.

Qualifications

• Bachelor's Degree required in finance, business administration, legal studies, or related field.

• Minimum 5 years relevant compliance, auditing, legal, consulting or related professional experience with preferred experience in the medical device, healthcare, or pharmaceutical industry

• Additional certification in Ethics and Compliance preferred.

• IT systems knowledge, Microsoft Office (must have Excel, PowerPoint, Word, Outlook, experience and PowerBI preferred)

• Experience with auditing and monitoring and cloud-based compliance software applications for auditing and monitoring and Concur, and contract management.

• Self-motivated, effective under pressure and proven ability to multi-task as well as assess and respond to changing priorities.

• Knowledge and experience with medical device aggregate spend solutions, master data management, and data associated with promotional and clinical data preferred.

• Experience developing business requirements and working with business functions to assess business processes to meet these requirements.

• Demonstrated knowledge of and experience with regulations for states with enacted marketing and disclosure reporting laws, restrictions, and tracking requirements is preferred.

• Strong analytical, problem solving, time management, organizational and interpersonal skills with the ability to work effectively with all levels within the organization.

• Must be flexible and willing to "get hands dirty" due to accomplish evolving tasks in start-up environment.

• Ability to lift a minimum of 20 lbs. Available to travel on an as-needed basis, up to 15%

Additional Information

Your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace's policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace is a drug free employer.