Associate Director, SOM

Date: Jan 14, 2023

Location: Plainfield, IN, US, 46168

Company: Apotex


Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

Job Summary

Reporting to the Associate Director, Site Lead (Indianapolis Distribution Center), the Associate Director, US Suspicious Order Monitoring (SOM) Program is responsible for implementing, executing, and enhancing our internal controlled substances analytics and compliance program.

As a subject matter expert on DEA regulations and lead of the Apotex Corp. Suspicious Order Monitoring Team (SOMT) comprised of members of Quality, Production, Commercial Operations, Regulatory Affairs, Global Logistics, Legal, Finance, and other areas, this position is instrumental in fulfilling the Company’s obligation to maintain the required closed system of narcotics distribution by implementing and improving our systems to detect and report suspicious orders of Apotex products.

Job Responsibilities

Execute US SOM Program activities

  • Co-chair the Suspicious Order Monitoring Team that provides oversight to the Apotex Corp. SOM program activities, along with the Program Manager, Corp. Quality & Compliance Controlled Substances
  • Develop, review, approve and measure effectiveness of all SOPs related to SOM; test electronic order review system. Identify changes that would enhance the process, and ensure that documentation is implemented
  • Analyze controlled substance orders and SOM data for diversion trends, and make appropriate recommendations
  • Investigate specific orders of interest and ensure timely completion of investigations coordinating with relevant stakeholders
  • Serve as escalation if the areas directly involved on the order release or cancellation recommendations require further assistance
  • Establish and monitor a central repository of documentation to ensure controlled substance documentation complies with federal /state regulatory requirements and is maintained in an inspection-ready state
  • Regularly monitor the timely reporting of the suspicious orders to the DEA
  • Regularly monitor the timely transmission of Suspicious Order Reports for states that require same.
  • Regularly monitor direct and downstream customer algorithms and thresholds to ensure systems are flagging orders appropriately
  • Review customer forecasts for products in scope
  • Conduct ongoing monitoring of internal chargeback data for all controlled substance products; independently investigate red flags
  • Collect and analyze data from disparate sources to make recommendations for restrictions and reinstatements according to SOPs
  • Monitor DEA and states for new reporting requirements and lead the implementation of those requirements
  • Regularly monitor SOM industry trends, best practices and guidance
  • Work with Global Information Services personnel when enhancements to the SOM system are required
  • Review SOM training materials regularly, make appropriate changes when necessary and train relevant stakeholders

Execute customer due diligence activities

  • Conduct controlled substance customer account set up due diligence reviews
  • Assess and improve new and existing controlled substance customer due diligence SOM questionnaires
  • Ensure the timely preparation and distribution of restriction letters to customers by the Customer Service team
  • Solicit due diligence feedback from distributors regarding pharmacies facing restriction
  • Monitor, audit and identify discrepancies between customer licenses
  • Prioritize in-person and/or remote reviews of wholesaler/distributor customers when/if deemed necessary; encourage SOM collaboration with wholesalers

Participate in Internal Audit Program Development & Execution

  • Participate in DEA and internal inspections/audits of the SOM program.
  • Maintain communications log of all information requests from law enforcement and regulatory agencies in accordance with company policy
  • Conduct mock DEA audits
  • All other relevant duties as assigned


Job Requirements

  • Education
    • University degree in science or Regulatory, Compliance, Law Enforcement or related program.
    • Background in pharmaceutical/chemical sector would be an
  • Knowledge, Skills and Abilities
    • In-depth knowledge in DEA regulations and standards as applicable to the pharmaceutical industry.
    • Working knowledge in Good Distribution Practices and application of Good Logistics Management principles would be an
    • Working knowledge with electronic Enterprise systems such as SAP (SAP preferred).
    • Clear and concise written and verbal communication in Apotex’ s language of
    • Demonstrated organizational skills and strong attention to
    • Demonstrated ability to effectively manage multiple priorities in a fast-paced
    • Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential
    • Work independently or in a team setting to achieve individual, departmental and organizational
    • Competent with computer systems and various software
  • Experience
    • 5-8 years of experience in DEA Compliance
    • Working knowledge and/ or hands-on experience with the Regulatory Systems would be an asset


At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Nearest Major Market: Indianapolis