Director, Controlled Substances Compliance

About the role

The Director of Controlled Substances Compliance reports to the Vice President, Head Litigation and Corporate Counsel, and leads Par Health's DEA compliance function. This role is central to the company's Anti-Diversion Program, focusing on controlled substances and diversion issues.

Responsibilities

• Member of Suspicious Order Monitoring Leadership Team
• Evaluation of annual algorithms for detecting unusual customer orders
• Reviewing chargeback restrictions and reinstatements
• Preparation and submission of annual DEA federal license renewals
• Attendance at Sales, Inventory, Operations and Planning meetings
• Development and maintenance of systems for all required DEA records
• Primary oversight for DEA and State agency controlled substances-related inspections
• Primary contact for DEA Washington, DC for quota, import/export permits, and certificates of registration escalations
• Delivery of presentations on the Company's Quota and Anti-Diversion Programs
• Review and oversight of discrepancy investigations
• Design and maintenance of an ongoing education program for internal employees on controlled substances compliance
• Active participation on cross-functional process improvement, product development, acquisition, external manufacturing, and other teams
• Timely destruction of controlled substances, including witness burn facilities and reverse distributor vendors
• Investigation of new controlled substances compliance concepts
• Supporting Legal requests and driving follow-up activities related to DEA inspections and discrepancy investigations
• Collaboration with Commercial and providing external support such as meetings with customers and professional organizations
• Evaluation of alternative supply chain arrangements
• Panel member at industry conferences on quota and ARCOS

Requirements

• Bachelor’s degree preferred or equivalent relevant experience
• 10 years of experience with the DEA required
• Experience in a pharmaceutical environment or other industry regulated by a federal agency preferred
• Previous supervisory/managerial experience required

Skills/Qualifications

• 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
• Familiarity with Microsoft Office: Excel (including pivot tables), PowerPoint, Word
• Working knowledge of data analytics and statistical process control

Relationships With Others

The Director, Controlled Substances Compliance interacts with many functions across the business, including leadership, as well as externally with attorneys, consultants, customers, the DEA, and State Boards of Pharmacy. The successful candidate must possess emotional intelligence to operate successfully in this role, balancing between DEA requests and internal stakeholders.

Working Conditions

Office based location in Hazelwood, MO with occasional travel to Company facilities in Missouri, New York, and Michigan, as well as to Washington, DC and customer sites throughout the US.