Compliance Manager (Auditing & Monitoring)

Compliance Manager, Auditing & Monitoring

The Corporate Compliance Manager will have primary responsibility for Back-End Monitoring (BEM) and related oversight activities at both the strategic and tactical level. This role will manage, coordinate, and conduct data monitoring, support internal investigations and audits, and manage and execute Azurity’s Risk Assessment and Mitigation Process (RAMP) and be responsible for Third Party Risk monitoring and mitigation.

Principle Responsibilities:Monitoring and Oversight:Lead and oversee the strategy, development and execution of ongoing Back-End Monitoring (BEM) activities, including document collection, review, oversight, tracking, and follow-up corrective actions. Areas will include activities such as HCP engagements, patient interactions, meals and other transfers of value, and Concur expense data. Ensure achievement of strategic goals.Maintain all related Compliance trackers (e.g., Issue Tracker, Management Action Plans, monitoring logs, and other oversight tools) to ensure completeness, accuracy, and timely follow-upPerform root cause analysis of noted compliance issues, trending of identified and emerging risks, and tracking of remediationFacilitate data collection efforts and analyses related to ad hoc requests from senior members of the Compliance teamOversee and review the work of contractors and temporary associates, as neededInvestigations & Audits:Provide investigation support, including information gathering, documentation, and coordination with internal stakeholdersManage the coordination of compliance audits and Risk Management, including planning, execution, interviews, and documentation of findings and outcomesRisk Assessment & Mitigation (RAMP):Responsible for the Risk Assessment and Mitigation Process (RAMP), including documentation of remediation outcomes, conducting trend analyses, and preparing executive-level reportsCompliance Program Support:Maintain Azurity’s Compliance incident management and reporting system, ensuring timely documentation, follow-up, and resolutionRecognize and respond promptly to compliance issues, escalating and addressing concerns to improve processes and communicationsCollaborate across Compliance functions to ensure alignment and consistency in monitoring, remediation, and reportingRecommend and implement new and updates to existing functional practices, policies and systemsPerform other departmental duties as assigned

Qualifications and Education RequirementsBachelor’s Degree in health science or related field10+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Bachelor's DegreeFull knowledge of healthcare laws and regulations under the FDA, fraud and abuse laws, privacy laws, industry codesExcellent analytical and problem-solving skills with the ability to organize and interpret complex data and identify trends to facilitate understanding of key information and provide actionable insights and recommendationsUnderstanding of simple statistical sampling methods to facilitate risk-based samplingSkilled at effectively communicating findings, trends/patterns, and recommendations both verbally and in writing to leadership and stakeholders through comprehensive reportsDemonstrated expertise in compliance monitoring, auditing, and issue remediationDemonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulationsProficiency with Microsoft Office Suite of products; intermediate to advanced level skills in Word, Outlook. Advanced skills in Excel and Power BI (e.g., V-Lookups, Pivot Tables, data queries, visualization, data import and format conversions), PowerPoint (e.g. development of slide decks including text and graphics), and Smartsheet (e.g. case tracking)Ability to build professional relationships with internal customers and partnersActs with a sense of urgency; high motivation and ability to take initiative, follow through, and complete projects in a professional and expeditious mannerProficiency with and/or ability to learn varied industry software products, such as Salesforce, Smart Sheets, SharePoint, Concur, and similar systems supporting day-to-day compliance operations.