Senior Compliance Manager

Cerapedics•Westminster, CO

13d•Onsite

About The Position

Cerapedics is a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair. This mission inspires us daily. We are seeking a Senior Compliance Manager to join our Legal team in our Westminster office. In this role, you will collaborate with internal clients at all levels of management and be empowered through meaningful work and career development to manage all aspects of the Compliance function's reporting requirements relating to the Federal Physician Payments Sunshine Act, and international, state and municipal transparency laws. A typical 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.

Requirements

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
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 investigations
Strong understanding of compliance processes and activities common to the medical device industry
Strong understanding of healthcare compliance and enforcement environment
Ability to develop strong trusting and productive relationships within and across the business areas to seek alignment on objectives and achieve results
Ability to work independently and prioritize in a rapid growth environment, with a sense of urgency
Excellent written and oral communication skills
High level of integrity with good ethical core values
Excellent time management and organizational skills
Strong attention to detail, organizational, analytical and people skills
Strong problem-solving skills to effectively envision, develop, and implement new strategies to address business issues and management requests

Nice To Haves

U.S. Healthcare Compliance Certification a plus

Responsibilities

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.