Manager, Controlled Substances Compliance; SOM

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

The Manager, Controlled Substances Compliance position is part of the Controlled Substances Compliance Team within the Mallinckrodt Specialty Generics business. The Manager is responsible for implementing, executing, and enhancing our internal controlled substances analytics and compliance program. This position is at the center of the Company’s industry‑leading Anti‑Diversion Program, which focuses on addressing the issues of diversion and abuse of our controlled substances.

As a subject matter expert on DEA regulations and a member of the Company’s Suspicious Order Monitoring Team (SOMT), this position is instrumental in fulfilling the Company’s obligation to maintain the required closed system of narcotics distribution by implementing and improving our systems to detect and report suspicious orders of finished dosage products and Active Pharmaceutical Ingredients (API) produced by the Company.

• Regularly review direct and downstream customer algorithms and thresholds to ensure systems are flagging orders appropriately
• Customer segmentation – conduct regular analysis and direct updates to segmentation into the inventory management system
• SOM enhancements – work with corporate Information Technology personnel when enhancements to the SOM system are required
• Primary responsibility for conducting ongoing reviews of internal chargeback data for all controlled substance products; independently investigate “red flags” and prepare pharmacy review cover sheets
• Solicit due diligence feedback from distributors regarding pharmacies facing restriction
• Collect and analyze data from disparate sources (DEA ARCOS data, census, state pharmacy board disciplinary information, social media information related to the pharmacy, information regarding proximity to pharmacies and other healthcare institutions, etc.) to make recommendations for restrictions and reinstatements according to standard operating procedures
• 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 – serve as member of the SOMT and facilitate media/internet and chargeback review meetings to include preparing agendas and documenting meeting minutes
• Prepare and send restriction letters to customers and DEA

• Provide second level SOM review of direct customer orders of controlled substances
• Review customer forecasts for focus products
• Contact 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
• Schedule and participate in customer reviews with CS Compliance staff
• Maintain KYC documents for all direct customers in accordance with SOPs
• Evaluate effectiveness of SOPs, identify changes that would enhance the process, and ensure that all change control documentation is implemented

• Evaluate effectiveness of standard operating procedures, identify changes that would enhance the process, and ensure that all change control documentation is implemented
• Directly participate in DEA inspections/audits. This participation will require skilled personal interface with external regulatory personnel
• Conduct mock DEA audits
• Maintain communications log of all information requests…