Responsibilities:
- Lead and oversee the strategy, development, and execution of ongoing Back-End Monitoring (BEM), including document collection/review, tracking, and follow-up corrective actions (e.g., HCP engagements, patient interactions, transfers of value, Concur expense data).
- Manage and conduct live monitoring; ensure issues are documented, escalated, and resolved.
- Maintain compliance trackers (issue tracker, management action plans, monitoring logs, oversight tools).
- Perform root cause analysis of compliance issues; trend emerging risks; track remediation.
- Support ad hoc compliance data collection/analysis for senior team members.
- Oversee/review contractors and temporary associates as needed.
- Provide investigation support (information gathering, documentation, coordination).
- Coordinate compliance audits (planning, execution, interviews, documentation of findings/outcomes) under Risk Management.
- Support Risk Assessment and Mitigation Process (RAMP): document remediation outcomes, conduct trend analyses, prepare executive reports; contribute to management action plans.
- Maintain the compliance incident management/reporting system; ensure timely documentation and resolution.
- Recognize/respond to compliance issues; escalate and address concerns; recommend updates to practices/policies/systems.
- Perform other duties as assigned.
Minimum Qualifications:
- Bachelor’s in health science or related field.
- 10+ years compliance experience in life sciences with Bachelor’s, or 8+ years with Master’s.
- 6+ years in corporate compliance monitoring, auditing, and investigations.
- Full knowledge of FDA healthcare laws, fraud/abuse, privacy laws, and industry codes.
- Strong analytics/problem-solving; ability to organize/interpret complex data and identify trends.
- Knowledge of statistical sampling for risk-based sampling.
- Excellent verbal/written communication; ability to report to leadership.
- Demonstrated compliance monitoring/auditing/issue remediation expertise.
- Knowledge of Anti-Kickback Statute, False Claims Act, FCPA, Sunshine Act, and related regulations.
- Proficiency with Microsoft Office (Excel/Power BI, PowerPoint) and Smartsheet; familiarity with tools like Veeva/SharePoint/Centris.
Preferred Qualifications:
- Master’s in health science or related field.
- 6+ years analyzing structured/unstructured data and visualizing risk/performance indicators.
- CCEP/ACFE/CIA (or equivalent).
- Data management/analytics background; prior field experience (commercial/medical).
Position Details:
- Home-based (Continental US); 35% national travel.