Endo · 1 month ago
Manager, Controlled Substances Compliance (SOM)
St Louis, MO
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expEndo is committed to developing and delivering life-enhancing products through focused execution. The Manager, Controlled Substances Compliance is responsible for implementing and enhancing the internal controlled substances analytics and compliance program, ensuring adherence to DEA regulations and managing the company's Anti-Diversion Program.
Pharmaceuticals
Responsibilities
Regularly review direct and downstream customer algorithms and thresholds to ensure systems are flagging orders appropriately
Conduct regular analysis and direct updates to segmentation into the inventory management system
Work with corporate Information Technology personnel when enhancements to the SOM system are required
Provide Second Level SOM review of direct customer orders of controlled substances
Review customer forecasts for focus products
Contacts direct customers for due diligence information when needed
Responsible for reviewing and updating customer due diligence questionnaires
Review and assess responses to questionnaires completed by customers
Schedules and participates in customer reviews with CS Compliance staff
Maintains KYC documents for all direct customers in accordance with SOPs
Evaluate effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented
Directly participate in DEA inspections/audits. This participation will require skilled personal interface with external regulatory personnel
Conducts mock DEA audits
Maintain communications log of all information requests from law enforcement and regulatory agencies in accordance with company policy
Manage a program of media/internet source reviews to identify downstream customers to be further investigated
Independently investigate downstream customers identified
Document investigation
Make recommendations for restrictions based upon the outcome of the investigation
Facilitate SOMT Meetings – Serves as member of the SOMT and facilitates media/internet and chargeback review meetings to include preparing agendas and documenting meeting minutes
Prepare and send restriction letters to customers and DEA
Qualification
Required
Bachelor's Degree
8 years of experience in Controlled Substance Compliance as an investigator/regulator
Previous experience with DEA recordkeeping and ARCOS reporting
Experience in data analytics including MS Excel pivot table work, charts, and graphs
Self-motivated with ability to work with various internal departments and external contacts
Understanding of and ability to interpret regulations
Ability to take initiative and act without direction when appropriate and ability to 'think and act on his/her feet'
Knowledge of regulatory reporting systems
Excellent oral and written communication skills
Detail-oriented
Working knowledge of Microsoft Office: Excel, PowerPoint, Word
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
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