Responsibilities:
- Lead development, execution, and continuous enhancement of the annual compliance audit and monitoring plan.
- Translate compliance risk priorities into audit strategies and monitoring activities.
- Oversee and review work of contractors/temporary associates as needed.
- Identify, assess, and prioritize compliance risks across business functions; align audit coverage to regulatory requirements and internal policies.
- Plan, coordinate, and conduct audits for adherence to FDA regulations, healthcare fraud and abuse laws, industry codes, and Company standards.
- Manage the full audit lifecycle (scoping, fieldwork, documentation, reporting, follow-up).
- Develop and maintain audit trackers/reporting tools; ensure timely escalation and resolution of findings.
- Partner on corrective action plans and monitor remediation to closure.
- Support compliance monitoring and internal investigations; strengthen controls by aligning audits, monitoring insights, and investigation outcomes.
- Serve as SME for healthcare compliance requirements; maintain/optimize compliance systems and tools.
- Collaborate with Legal, Risk Management, Finance, and business teams; provide guidance/training.
- Prepare and present audit results, trends, and risk insights; drive continuous improvement.
Minimum Requirements:
- Bachelor’s degree (business/finance/life sciences/healthcare).
- 15+ years compliance experience (or 13+ with Master’s, or 10+ with PhD) in life sciences; 10+ years in corporate compliance auditing/monitoring/investigations.
- Advanced knowledge of AKS, FCA, HIPAA, FCPA, Sunshine Act.
- Independent judgment in risk prioritization/escalation; strong data analysis/reporting; executive communication.
- Proficiency: Microsoft Office; Power BI, Veeva, SharePoint.
Preferred Qualifications:
- Master’s or PhD in relevant field.
- 8+ years analyzing structured/unstructured data for risk/performance indicators.
- CCEP, CFE, or CIA (or equivalent).
Position Details/Benefits:
- Home-based; preference for Eastern Time Zone; 30% annual travel.
- Eligible for comprehensive benefits (medical/dental/vision/prescription, wellness, 401k/ESPP, PTO/paid parental leave, disability, and more).