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Specialist, Controlled Substances Compliance - Analyst

Endo

Webster Groves, MOOnsitePosted 43 days ago
Full TimeMid LevelQuality (QA / QC)Pharmaceutical
Original posting ↗

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.

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