Develop and maintain the annual risk-based monitoring plan, including collaboration with third-party consultants to support execution and continuous program improvement
Lead and execute live (in-person and virtual) and transactional/desktop monitoring in partnership with other compliance team members and third-party consultants
Define, track, and report key performance indicators (KPIs) and key risk indicators (KRIs) to assess compliance risk trends and monitoring program effectiveness
Analyze monitoring data to identify trends, outliers, and emerging risk signals that inform monitoring priorities
Oversee remediation and corrective action plans, including tracking progress and ensuring timely and effective resolution of monitoring findings
Develop and maintain monitoring dashboards and reports (e.g., Excel, Tableau, Power BI, monitoring system)
Translate analytics and monitoring results into clear, executive-ready insights
Support monitoring system implementation and ongoing enhancement efforts
Partner cross-functionally with Commercial, Medical, Finance, IT, HR, and other stakeholders to align compliance activities
Provide compliance operational guidance and support for additional compliance initiatives, as needed
Requirements
Bachelor’s degree required; advanced degree or relevant certification preferred
At least 8 years of experience in healthcare compliance monitoring or operations within the pharmaceutical, biotechnology, or life sciences industry, or 6 years with an advanced degree or relevant certification
Demonstrated knowledge of pharmaceutical compliance laws, regulations, and industry guidance (e.g., OIG, PhRMA, anti-kickback, anti-bribery)
Recent, hands-on experience with live field and transactional compliance monitoring
Advanced proficiency in Excel; experience with data visualization and dashboarding tools (e.g., Tableau, Power BI)
Demonstrated ability to analyze large datasets to identify trends, outliers, and compliance risks
Experience with compliance monitoring systems, including automated/AI-enabled monitoring tools, preferred
Proven ability to manage complex projects and external vendors effectively
Ability to operate independently and collaboratively in a fast-paced, matrixed environment, while exercising sound judgment
Effective verbal and written communication skills with the ability to convey complex information to diverse audiences
Demonstrated initiative, adaptability, and willingness to take on new responsibilities as business needs evolve
High degree of integrity and discretion in handling proprietary and confidential information