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.
Job Description Summary
Job Description
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.
Job Description
Essential Functions
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
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.) in order 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 - 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
Direct Customer Orders Reviewed & Dispositioned
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.
Know Your Customer (KYC) Program
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.
Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
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
Maintain communications log of all information requests from law enforcement and regulatory agencies in accordance with company policy
Minimum Requirements
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
Organizational Relationship/Scope
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 workflow; 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.
Working Conditions
This position is preferred office based in St. Louis, Missouri.
This position is eligible to be field based with a travel requirement 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.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.?
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
