Regulatory Specialist, Controlled Substances - Dublin, OH - Sarnova

Summary:

The Controlled Substance Regulatory Specialist is responsible for the Company’s internal controlled substance compliance auditing, customer due diligence, and DEA inspection readiness. This role independently tests the controls that govern controlled substance operations and customer licensing, conducts enhanced due diligence on controlled substance customers, and owns the Ohio controlled substance customer annual due diligence program, as well as other responsibilities as assigned.

Organizational Impact:

The Controlled Substance Regulatory Specialist plays a critical role in protecting the Company’s compliance posture and maintaining the integrity of controlled substance operations. By conducting independent audits, performing customer due diligence, supporting DEA inspection readiness, and identifying potential compliance risks, this role helps mitigate regulatory exposure, prevent diversion, and safeguard the Company's licenses and reputation. The position provides oversight and accountability for key controlled substance compliance processes while partnering cross-functionally to strengthen controls, drive continuous improvement, and ensure adherence to federal, state, and company regulatory requirements.

Essential Duties and Responsibilities:

• Complete the Company’s suspicious order monitoring program order of interest due diligence.
• Own the Ohio controlled substance customer annual due diligence program
• Publish and maintain the Suspicious Order Monitoring due diligence protocol as a work instruction
• Conduct internal compliance audits of Operations controlled substance functions and Customer Licensing operations, and document findings, corrective actions, and closure
• Establish and maintain a recurring internal audit cadence and annual audit plan covering controlled substance and customer licensing controls
• Assist with DEA inspection preparation and support inspection readiness across distribution facilities
• Perform enhanced customer due diligence on randomly selected Bound Tree Medical controlled substance customers, and establish the randomized selection methodology
• Collaborate with Operations, Quality, and Customer Licensing to develop and implement processes that close gaps identified in audit findings, inspections, and regulatory changes.
• Escalate controlled substance diversion risk and reportable findings to the Director & Senior Regulatory Counsel
• Perform new drug item setup, with emphasis on controlled substances
• Perform additional duties as assigned

Skills/Experience Required:

• Education: Bachelor’s degree required
• Direct experience with controlled substance regulations, customer due diligence, or internal auditing desired
• Demonstrated familiarity with DEA, FDA, and state controlled substance regulations, including suspicious order monitoring and customer due diligence obligations
• Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes
• Sound investigative and analytical judgment, with the ability to test information against source records rather than accept it as reported
• Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies
• Strong written and verbal communication skills, including clear documentation of audit findings and due diligence conclusions
• Well-developed organizational and cross functional skills, with the ability to manage recurring compliance cycles to deadline
• Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software

Physical Requirements:

• Sit, walk, stand, use hands to manipulate, handle, feel, and control items or equipment
• Reach with hands and arms
• Talk and hear
• See and be able to read, write, and interpret text
• Employee may use computer, phone, copier and other office equipment in the course of a day
• Occasionally lift and move objects weighing up to 10 pounds
• Employee may be required to travel for business purposes
• When working remotely, ability to secure confidential information
• When working remotely, perform all duties in a professional environment free of noise or anything that would create a negative customer experience

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Continuous is defined as 6-8 hours, frequently is defined as 3-6 hours, and occasionally is defined as up to 3 hours.

Work Schedule: Employee will be required to work a minimum of forty (40) hours of per week or as many hours as it may take to perform above job duties. Schedule may vary based on business demands and will require a combination of office hours as well as work performed after hours and/or weekends at times.

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients’ lives.  Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day.  We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.