Senior Compliance Manager

ABOUT US

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide:
Pearl Matrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado.

Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Senior Compliance Managerin our Westminsteroffice.

In this role, you will contribute to our mission through collaborating with internal clients at all levels of management. As a Senior Compliance Manager working on the Legalteam, you will be empowered through meaningful work and career development to manage all aspects of the Compliance function's reportingrequirementsrelating to the Federal Physician Payments Sunshine Act, and international, state and municipal transparency laws. Atypical day will include- providing counseling on healthcare compliance issues;

working closely with the Compliance Officer on strategic compliance matters; providing support on the general compliance needs of the company; and collaborating with key stakeholders to develop, review and/or deliver compliant training materials for internal and external audiences.

• Oversee and collaborate across internal teams and external partners to manage State and Federal Transparency reporting obligations, including review, remediation, and accurate aggregate spend reporting—under the Federal Sunshine Act and applicable international, state and municipal laws, ensuring data integrity across multiple systems and vendors.
• Work closely with the Compliance Officer and General Counsel to develop and maintain an aggregate spend assumptions and interpretations document and remain current with aggregate spend related laws and regulations, for timely implementation of updates to this document.
• Work with the Compliance Officer to monitor, audit, and investigate to ensure that any allegation or identified violation of company policy related to aggregate spend is properly investigated, remediation taken, and monitor controls established to prevent future instances.
• Develop and implement effective training and communication initiatives related to aggregate spend and state reporting for senior management, employees, customers and third-party vendors.
• Coordinate, conduct, and report corrective action planning on compliance trainings, education, auditing, and monitoring, including periodic field rides, trade show attendance, and company sponsored HCP educational events.
• Conduct and support the management of compliance investigations and enforcement in collaboration with the Legal Department.
• Support Compliance review, approval, and processing of Healthcare Professional engagements and contracting to ensure compliance with applicable laws.
• Development and publish quarterly Compliance metrics.
• Provide training on a wide range of issues related to compliance, including policies and guidelines applicable to labeling and promotional content, reimbursement, and interactions with healthcare providers.

• Bachelors Degree required
• Minimum 8 years of healthcare industry compliance experience required, preferably in a global pharmaceutical or medical device company
• Sunshine Act and transparency reporting experience required
• U.S. Healthcare Compliance Certification a plus

• Strong knowledge of OIG seven elements, False Claims Act, Anti-kickback Statute, and anti-bribery considerations
• Experience working with Commercial and Medical Affairs functions
• Experience managing compliance and ethics…