Director, Controlled Substances Compliance

Endo•Hazelwood, MO

2d•Hybrid

About The Position

The Director of Controlled Substances Compliance reports to the Vice President, Head Litigation and Corporate Counsel, and leads Par Health’s (the “Company’s”) Drug Enforcement Administration (DEA) compliance function, which is a critical part of the continued success of the business. This position is also at the center of the Company’s industry-leading Anti-Diversion Program, which focuses on addressing the issues of diversion and abuse of controlled substances products. The position requires in-depth knowledge of DEA regulations and the ability to interact in a professional manner with Company leadership, personnel from the DEA Field Offices and DEA Headquarters, and representatives from large wholesale and retail chain customers. The Director of Controlled Substances Compliance is responsible for synchronizing controlled substances reporting, quota requests, quota tracking, DEA audit preparedness across sites (St. Louis, MO; Fenton, MO; Hobart, NY; Webster Groves, MO; and Rochester, MI) as well as interacting with various functions across the business including Commercial, Supply Chain, Customer Service, Manufacturing, Quality, and Trade Compliance. As a subject matter expert on DEA regulations, this position is ultimately accountable for the Company’s systems and procedures to maintain the required closed system of narcotics distribution including: DEA and State registration license renewals, quota consumption monitoring, quota request submissions, DEA ARCOS reporting and State-mandated reporting, comprehensive recordkeeping, complete and accurate year end physical inventory counts, inventory reconciliation, discrepancy investigations, DEA narcotic raw material reports and DEA Close of Business Reports. This position has primary leadership responsibilities for all DEA and State agency controlled substances-related inspections. Additionally, the Director of Controlled Substances Compliance is the primary contact for DEA Washington, DC when escalation is required for issues relating to quota, import/export permits and certificates of registration. The Director of Controlled Substances Compliance participates in customer visits and delivers presentations covering the Company’s Quota and Anti-Diversion Programs.

Requirements

10 years of experience with the DEA required
Previous supervisory/managerial experience required
Self-motivated - able to work with various departments internally and contacts outside of the organization
Understanding of the rulemaking process and interpretation of regulations
Must take initiative and act without direction when appropriate and ability to “act on his/her feet”
Knowledge of regulatory reporting systems
Excellent oral and written communication skills
Detail-oriented
Previous experience with DEA recordkeeping and DEA ARCOS reporting
Working knowledge of Microsoft Office: Excel (including pivot tables), PowerPoint, Word
Familiarity with data analytics and statistical process control

Nice To Haves

Bachelor’s degree preferred or equivalent relevant experience
Experience in a pharmaceutical environment or other industry regulated by a federal agency preferred

Responsibilities

Member of Suspicious Order Monitoring Leadership Team including evaluation of annual algorithms designed to detect customer orders of unusual pattern, size or frequency.
Extensive work reviewing chargeback restrictions and reinstatements.
Accountable for the preparation and submission of annual DEA federal license renewals.
Oversees each facility’s input for monthly planning cycle and attends Sales, Inventory, Operations and Planning meetings on a monthly basis.
Accountable for developing and maintaining systems for all required DEA records per record retention policy.
Serve as the primary oversight representative for the Company on all controlled substances-related visits and audits by DEA, State Boards of Pharmacy, and other regulatory entities.
Accountable for assuring a complete and accurate DEA year-end inventory.
Interfaces regularly with external customers and vendors on controlled substances compliance matters.
Provides oversight for review of discrepancy investigations from the controlled substances compliance perspective, which involves tracking through external parties (carriers, distributors, and 3PLs) and internally with Customer Service and distribution centers.
Develop, maintain, and continually improve internal audit program for controlled substances compliance.
Design and maintain an ongoing and updated education program for internal employees on controlled substances compliance as pertains to quota and anti-diversion programs.
Provides controlled substances compliance expertise through active participation on cross-functional process improvement, product development, acquisition, external manufacturing and other teams.
Management responsibility for timely destruction of controlled substances in collaboration with internal clients (EH&S, Manufacturing, Laboratories), witness burn facilities and reverse distributor vendors.
Assure that destruction transactions are entered in a timely manner.
Investigate on an ongoing basis new controlled substances compliance concepts through continued education, seminars, training, and opportunities to participate in regulation and policymaking.
Special projects as required, including supporting Legal requests.
Drive follow-up activities related to DEA inspections and discrepancy investigations.
Extensive interaction with Commercial and Supply Chain on quota matters and Customer Service on customer diligence and ordering, including initiation of improvement projects to enhance controlled substances order management processes related to controlled substances, CSOS and DEA Form 222 transactions.
Collaborate with Commercial and provide external support such as meetings with customers and professional organizations.
Evaluate alternative supply chain arrangements such as 3PL providers and distribution network for specialized products.
Subject matter expert on complex quota matters.
Panel member at industry conference on topics of quota and ARCOS.
Other duties as assigned by the Vice President, Head Litigation and Corporate Counsel.