Senior Manager Controlled Substances
Core
Leads the development, implementation, and oversight of policies and controls to ensure organizational adherence to federal, state, and international regulatory requirements for controlled substances.
Role type
Senior Manager, Regulatory Compliance (Controlled Substances)
Builds
An effective, data-driven compliance program and internal controls for controlled substance distribution.
Domain
Healthcare distribution / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Federal and state controlled substance regulations expertise, compliance policy development, audit and monitoring program leadership, regulatory investigation management, team leadership and development, cross-functional collaboration, ARCOS reporting, suspicious order monitoring, DEA Form 106 filings, inventory and chain-of-custody controls.
Preferred skills
Master's degree in regulatory/legal/business/healthcare, leading enterprise-level compliance programs, familiarity with regulatory reporting platforms and auditing systems.
Technologies
Regulatory reporting platforms, auditing systems
Responsibilities
Develop and oversee compliance policies and internal controls; lead compliance audit and monitoring programs; monitor emerging regulatory requirements and interpret legislation; oversee investigations of misconduct and regulatory violations; provide strategic leadership in compliance training; serve as primary liaison with regulatory authorities; direct and develop a high-performing compliance team; collaborate cross-functionally with Legal, Operations, Sales, and Supply Chain; oversee ARCOS reporting and suspicious order monitoring; direct investigations involving controlled substances including diversion and theft events; ensure compliance with operational requirements for receipt, storage, distribution, and disposal of controlled substances.
Seniority
Senior, hands-on IC with people management responsibilities
