Senior Compliance Manager
$146k - $211kAmerican Statistical Association - ASA
Senior Compliance ManagerCerapedics 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: PearlMatrix 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 Manager in our Westminster office.This is an onsite position.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 Legal team, you will 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.Position Objectives: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.Position Requirements:Bachelors Degree requiredMinimum 8 years of healthcare industry compliance experience required, preferably in a global pharmaceutical or medical device companySunshine Act and transparency reporting experience requiredU.S. Healthcare Compliance Certification a plusEducation and Preferred Training Requirements:Strong knowledge of OIG seven elements, False Claims Act, Anti-kickback Statute, and anti-bribery considerationsExperience working with Commercial and Medical Affairs functionsExperience managing compliance and ethics investigationsStrong understanding of compliance processes and activities common to the medical device industryStrong understanding of healthcare compliance and enforcement environmentAbility to develop strong trusting and productive relationships within and across the business areas to seek alignment on objectives and achieve resultsAbility to work independently and prioritize in a rapid growth environment, with a sense of urgencyExcellent written and oral communication skillsHigh level of integrity with good ethical core valuesExcellent time management and organizational skillsStrong attention to detail, organizational, analytical and people skillsStrong problem-solving skills to effectively envision, develop, and implement new strategies to address business issues and management requestsWork Condition/Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.Travel Requirements:It is anticipated that the Senior Compliance Manager will travel (up to 25% of time) (i) to observe field staff and (ii) to monitor company sponsored events.Benefits/Compensation (including, but not limited to):Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.Salary Range:$146,000.00 - $211,000.00Base Salary:AnnuallyTarget Annual Bonus:Up to 20%EEO Statement:Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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