Compliance (Regulatory) Manager

Description

POSITION SUMMARY

This position is responsible for developing, implementing and coordinating processes and procedures to ensure compliance with all applicable state and federal regulations including Drug Enforcement Agency and State Board of Pharmacy. In addition, this position will serve in a staff (advisory) capacity for the processes related to compliance with the distribution center, controlled substance cage and vault. This position is on-site.

Requirements

• Serves as the primary back-up for the Sr. Compliance Coordinator
• Approves CII-V’s orders (including checking customer limits)
• Suspicious order monitoring (SOM)
• Covers for the Sr. Compliance Coordinator during their absence
• Coordinates new account licensing
• Sets up licensing on new vendor accounts; new inventory items
• Serves as the liaison between IT and Compliance for various projects such as automation and AI assistance
• Coordinates the ARCOS reporting process
• Coordinates the process for expired/expiring customer licenses
• Maintains customer restrictions
• Serves as liaison between IT and Compliance for automation and AI assistance
• Standard Operating Procedures (SOP) creating, revision, maintenance and training
• Responds to audit requests in Sr. Compliance Coordinator’s absence
• Maintains visibility of C2 products on the CSOS website based on inventory and inactive items
• Sets up accounts on the CSOS website to allow Electronic 222 ordering
• Completes accountability audits of warehouse and compliance processes
• Affords support to Compliance Clerks as needed
• Reviews questionnaires for completeness
• Coordinates and assists with the expired license review
• Other duties as required

Position Qualifications

• Competency Statement(s): Accountability, Analytical Skills, Assertiveness, Communication, Oral, Decision Making, Tactful, Accuracy, Problem Solving, Time Management Skills, Honesty / Integrity, Detail Oriented, Organized
• Education: Bachelor’s Degree; or Work Equivalent
• Experience: Five+ years' experience in Regulatory Compliance. Project Management experience; PME Certification preferred, Six Sigma experience preferred, Training experience preferred, and Records Management experience preferred
• Computer Skills: Must have a strong working knowledge of the Microsoft Office Suite of products with specific knowledge of Excel, Word and Outlook. In addition, must be able to work fluidly with the AS400 and the company operating software and systems to function effectively in this position.
• Certifications & Licenses: Must be able to achieve the status of Certified Designated Representative in California within one year of tenure in the position and Florida within two years of tenure in the position.