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

ESSENTIAL FUNCTIONS:

Reasonable Accommodations Statement

To accomplish this job successfully, an individual must be able to perform each essential function satisfactorily, with or without reasonable accommodation. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statements

• Serves as the primary back-up for the Sr. Compliance Coordinator
• Approves CII-V’s orders (including checking customer limits)
• Suspicious order monitoring (SOM)
• Coordinates new account licensing
• Set 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
• Assists in implementing new programs to streamline and automate compliance tasks
• Assists 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 - Ability to accept responsibility and account for his/her actions.

· Analytical Skills - Ability to use thinking and reasoning to solve a problem.

· Assertiveness - Ability to act in a self-confident manner to facilitate completion of a work assignment or to defend a position or idea.

· Communication, Oral - Ability to communicate effectively with others using the spoken word.

· Decision Making - Ability to make critical decisions while following company procedures.

· Tactful - Ability to show consideration for and maintain good relations with others.

· Accuracy - Ability to perform work accurately and thoroughly.

· Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.

· Time Management Skills - Ability to organize and direct oneself in a fast paced, time sensitive environment.

· Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.

· Detail Oriented - Ability to pay attention to the minute details of a project or task.

· Organized - Possessing the trait of being organized or following a systematic method of performing a task.

SKILLS & ABILITIES

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.

Other Requirements: None

PHYSICAL DEMANDS

N (Not Applicable) Activity is not applicable to this position.

O (Occasionally) Position requires this activity up to 33% of the time (0 - 2.5 hrs/day)

F (Frequently) Position requires this activity from 33% - 66% of the time (2.5 - 5.5 hrs/day)

C (Constantly) Position requires this activity more than 66% of the time (5.5 hrs/day)