Specialist, Controlled Substances Compliance - Analyst
Par Health
Summary
The Specialist, Controlled Substances Compliance - Analyst position reviews direct customer orders flagged for review and participates in a multi-level process to evaluate and recommend disposition of the order in accordance with company policy; review customer questionnaires for completeness and accuracy and conducts appropriate follow-up with customers as necessary; audits internal processes to ensure compliance with company policies and procedures; facilitates activities of the Suspicious Order Monitoring Team (SOMT).
Job description
Essential Functions
Direct Customer Orders Reviewed & Dispositioned
- Conducts first-level review of direct customer orders flagged by company algorithms and recommends whether they may be released per SOPs.
- Coordinates with the Commercial business unit representatives (National Account Directors and Product Managers) to gather the information (forecasts, etc) necessary to aid decision making on flagged orders.
- Review customer forecasts for focus products
- Contacts direct customers for due diligence information when needed.
- Creates and maintains the documentation necessary to satisfy the DEA’s requirement for the reporting of suspicious orders per record retention policy.
- Reviews Direct Order Dashboard and other company data to detect patterns that may be related to a specific customer account.
- Track metrics for reporting to the Suspicious Order Monitoring Team.
Know Your Customer (KYC) Program
- Reviews direct customer KYC questionnaires for completeness and thoroughness.
- 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.
Support Suspicious Order Monitoring Team
- Assist with managing a program of media/internet source reviews to identify downstream customers to be further investigated.
- Facilitate SOMT Meetings – Preparing meeting minutes.
- Prepare and send notices to DEA of pharmacy restrictions
Minimum Requirements
Education: Bachelor’s degree or equivalent relevant experience, including statistical analysis preferred.
Experience: Prior experience in Controlled Substance Compliance in the private sector or as a government investigator/regulator preferred.
Preferred Skills/Competencies
- Experience in data analytics including Excel pivot tables and charts, graphs.
- Working knowledge of Word and PowerPoint.
- Experience auditing internal processes to ensure compliance with regulations and company policies and procedures.
- Self-motivated; able to work with various departments internally and contacts outside of the organization.
- Must take initiative and act without direction when appropriate.
- Knowledge of regulatory reporting systems.
- Previous experience with DEA recordkeeping.
- Excellent oral and written communication skills.
- Detail oriented.
- Strong organizational skills.
Requirements
- Bachelor’s degree or equivalent relevant experience
- Prior experience in Controlled Substance Compliance in the private sector or as a government investigator/regulator preferred
- Experience in data analytics including Excel pivot tables and charts, graphs
- Working knowledge of Word and PowerPoint
- Experience auditing internal processes to ensure compliance with regulations and company policies and procedures
- Self-motivated; able to work with various departments internally and contacts outside of the organization
- Must take initiative and act without direction when appropriate
- Knowledge of regulatory reporting systems
- Previous experience with DEA recordkeeping
- Excellent oral and written communication skills
- Detail oriented
- Strong organizational skills
Company overview
Par Health is a leading pharmaceutical company specializing in the development, manufacturing, and distribution of high-quality generic medicines, active pharmaceutical ingredients (APIs), and sterile injectable products. Established as an independent entity following the spin-off from Mallinckrodt in 2025, the company operates with a mission to "Elevate the Essentials" in healthcare. With over 4,000 employees globally and a vertically integrated manufacturing network spanning seven U.S. facilities and additional operations in India, Par Health has established itself as a top 15 U.S. generic medicines manufacturer and the largest U.S. producer of APIs by volume. The company's portfolio comprises approximately 200 products across multiple therapeutic areas, dosage forms, and delivery technologies, serving hospitals, health systems, clinics, retail pharmacies, and government agencies. Par Health is recognized for its industry-leading reputation in quality, compliance, reliability, and service, with a robust track record of regulatory excellence and no warning letters from over 20 regulatory inspections in the past five years. The company's vertically integrated approach provides end-to-end control over quality and production speed, offering strategic advantages in product reliability and regulatory compliance.