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About the role
Key responsibilities & impact- Reports to the Vice President, Head Litigation and Corporate Counsel
- Leads the Company’s Drug Enforcement Administration (DEA) compliance function
- Responsible for synchronizing controlled substances reporting, quota requests, quota tracking, and DEA audit preparedness
- Accountable for the Company’s systems and procedures to maintain the required closed system of narcotics distribution
- Primary leadership for all DEA and State agency controlled substances-related inspections
- Oversight for review of discrepancy investigations from the controlled substances compliance perspective
- Develop, maintain, and continually improve internal audit program for controlled substances compliance
- Serves as primary oversight representative for the Company on all controlled substances-related visits and audits
- Interfaces regularly with external customers and vendors on controlled substances compliance matters
- Provides controlled substances compliance expertise through active participation on cross-functional process improvement
Requirements
What you’ll need- 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
- 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
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
DEA compliancecontrolled substances reportingquota trackinginternal audit programregulatory reporting systemsDEA recordkeepingDEA ARCOS reportingdata analyticsstatistical process control
Soft Skills
leadershipself-motivatedinitiativecommunication skillsdetail-oriented
