Job Title

Requisition

Location

Additional Locations

Job Description

The Manager, Controlled Substances Compliance position is part of the Controlled Substances Compliance Team within the Mallinckrodt Specialty Generics business. The Manager Controlled Substances Compliance role is vital to the Company's U.S. Drug Enforcement Administration (DEA) compliance function, which is a critical part of the continued success of the Company's Specialty Generics business. The role 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.

Suspicious Order Monitoring

• 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

• Provide Second Level SOM review of direct customer orders of controlled substances

• Review customer forecasts for focus products

• Responsible for secondary review of direct customer due diligence questionnaires

  • Review and assess responses to questionnaires completed by direct customers

• 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.)

  • Independently investigate downstream customers identified

  • Document investigation

  • Make recommendations for restrictions based upon the outcome of the investigation

• 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

• Interact with the DEA and other regulatory agencies in support of inspections and information requests

• Responsible for monitoring states for new reporting requirements and implementing those requirements

• Maintain communications log of all information requests from law enforcement and regulatory agencies in accordance with company policy

• Organize and maintain regular schedule of in-person and/or remote reviews of wholesaler/distributor customers and encourage SOM collaboration with wholesalers

Internal Audit Program Development & Execution

• 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

• Conducts mock DEA audits

• Bachelor's Degree

• 8 years of experience in Controlled Substance Compliance as an investigator/regulator

• Experience in data analytics including MS Excel pivot table work and charts, graphs

• Understanding of and ability to interpret regulations

• Knowledge of regulatory reporting systems

• Previous experience with DEA recordkeeping and ARCOS reporting

Preferred Skills

• Self-motivated with ability to work with various internal departments and external contacts

• Ability to take initiative and act without direction when appropriate and ability to "think and act on his/her feet"

• Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.

• Escalation Process Adherence: Understands the scope of his/her decision-making authority; sorts through the facts and personal knowledge level to determine if an issue can be managed effectively or if it needs to be elevated to someone with additional knowledge that would impact the outcome; does not let much time lapse prior to making the decision to let others know; clearly and concisely explains the issue to senior leadership; ensures handoff to the next level has occurred.

• Priority Setting: Spends his/her time and the time of others on what is important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others cannot; can simplify complex processes; gets more out of fewer resources.

• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.

This position interacts within all levels of the organization from the manufacturing floor to senior leaders. This position will also interact with external regulatory agencies on behalf of the company.

This position is preferred office based in St. Louis, Missouri and is eligible for relocation assistance.

This position requires field based travel of at least 50%. Travel is inclusive of frequent visits to other Mallinckrodt and/or Customer sites that may include traditional office setting, production areas, loading docks, and laboratories.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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