Specialist, Controlled Substances Compliance - Analyst
Endo
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
- 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
- Knowledge of regulatory reporting systems
- Previous experience with DEA recordkeeping
- Excellent oral and written communication skills
- Detail oriented
- Strong organizational skills
Company overview
Endo is a diversified specialty pharmaceutical company headquartered in Malvern, Pennsylvania, founded in 1997. As a global pharmaceutical manufacturer, Endo develops and markets high-value branded pharmaceutical products across therapeutic areas including urology, men's health, orthopedics, and endocrinology. The company operates as a subsidiary of Endo International plc and has established itself as a leader in both branded and generic pharmaceuticals, with a portfolio of over 200 product families. Endo's mission focuses on helping everyone they serve live their best life through the delivery of life-enhancing therapies. The company maintains manufacturing and research facilities across multiple continents, including the United States, Ireland, Canada, and India, employing approximately 2,100-3,100 professionals globally. In 2025, Endo completed a significant merger with Mallinckrodt Pharmaceuticals, resulting in the creation of two focused standalone companies: Keenova Therapeutics for branded therapeutics and Par Health for generics and sterile injectables.