Senior Corporate Compliance Manager – Monitoring
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Job Description
Senior Corporate Compliance Manager responsible for Back-End Monitoring and compliance management in biotech. Leading investigations, audits, and risk assessments for internal compliance processes.
Responsibilities:
- The Senior 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 live monitoring, support internal investigations and audits, and provide support in managing associated tasks for UT's Risk Assessment and Mitigation Process (RAMP).
- 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.
- Ensure achievement of strategic goals.
- Manage, coordinate, and conduct live monitoring activities, ensuring issues are documented, escalated, and resolved appropriately
- 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-up
- Perform root cause analysis of noted compliance issues, trending of identified and emerging risks, and tracking of remediation
- Facilitate data collection efforts and analyses related to ad hoc requests from senior members of the Compliance team
- Oversee and review the work of contractors and temporary associates, as needed
- Provide investigation support, including information gathering, documentation, and coordination with internal stakeholders
- Manage the coordination of compliance audits, under the direction of Risk Management, including planning, execution, interviews, and documentation of findings and outcomes
- Support UT’s Risk Assessment and Mitigation Process (RAMP), including documentation of remediation outcomes, conducting trend analyses, and preparing executive-level reports
- Maintain UT’s Compliance incident management and reporting system, ensuring timely documentation, follow-up, and resolution
- Recognize and respond promptly to compliance issues, escalating and addressing concerns to improve processes and communications
- Collaborate across Compliance functions to ensure alignment and consistency in monitoring, remediation, and reporting
- Recommend and implement new and updates to existing functional practices, policies and systems
- Perform other departmental duties as assigned
Requirements:
- Bachelor’s Degree in health science or related field
- 10+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Bachelor's Degree or 8+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Master's Degree
- 6+ years of experience in corporate compliance monitoring, auditing, and investigations roles
- Full knowledge of healthcare laws and regulations under the FDA, fraud and abuse laws, privacy laws, industry codes
- Excellent 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 recommendations
- Understanding of simple statistical sampling methods to facilitate risk-based sampling
- Skilled at effectively communicating findings, trends/patterns, and recommendations both verbally and in writing to leadership and stakeholders through comprehensive reports
- Demonstrated expertise in compliance monitoring, auditing, and issue remediation
- Demonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulations
- Proficiency 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 partners
- Acts with a sense of urgency; high motivation and ability to take initiative, follow through, and complete projects in a professional and expeditious manner
- Proficiency with and/or ability to learn varied industry software products, such as Veeva, Smart Sheets, Sharepoint, Centris, and similar systems supporting day-to-day compliance operations
Benefits:
- medical / dental / vision / prescription coverage
- employee wellness resources
- savings plans (401k and ESPP)
- paid time off & paid parental leave benefits
- disability benefits
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