Company Overview

Our client is one of the leading companies in Puerto Rico in the distribution of pharmaceutical, health, consumer, and veterinary products. They are seeking a Compliance Officer.

Job Summary

Compliance Officer, role is responsible for assuring compliance with controlled substances local and federal regulations as they apply to a distributor.
Experienced compliance officer guarantees that Company processes and transactions follow all DEA requirements for controlled substance based on program commitment to the agency, following the policies and procedures of the company.

Responsibilities and Duties

• Manage effective compliance with the Controlled Substance Program (CSP). This includes continuous improvement of the program, as needed.
• Is responsible for enforcing compliance with the guidelines, procedures, and standards to maintain the operation in compliance with the requirements of the regulatory agency (DEA, Department of Health of Puerto Rico, FDA, and any other applicable).
• Develop and review Company, policies and procedures related directly or indirectly to controlled substances.
• Inspection Leader for DEA/Regulatory audits and Company Management Liaison.
• Create and manage effective action plans in response to audit compliance violations
• Audit procedures, practices, and documents to identify possible weaknesses or risks.
• Assess company operations and DEA commitments to determine compliance risk.
• Ensure all employees related to CSP operation are trained in current procedures.
• Resolve employee concerns about compliance evaluate risks and recommend action plans.
• Support and collaborate with Regulatory Affairs and Quality department, as well as with Operations and Management in everything related to controlled substances processes and regulations.
• Monitor and ensure compliance with any agreements made with regulatory agencies, suppliers, and clients, regarding controlled substances.
• Analyze data to identify and report trends and patterns and provide recommendations on such trends.
• Participate in management reviews to report on compliance situations and proposed solutions. Create metrics to monitor and report the level of regulatory risk to Company Management.
• Review and approve; Threshold Changes, Suspicious Order Investigation, New customer Assessment Reports, Periodic Reports to DEA, Customer Assessment Reports, and any regulatory report/communications.
•  Overseeing CP Programs; SO, Evaluation Program, Customer Assessment Program, Threshold Increase Process, Compliance with DEA commitments, Document Management System related to DEA.

• Bachelor’s degree in science, healthcare, finance, business management, or a related field and 5 years of proven experience in a compliance role; or the equivalent combination of education and experience. Domain of Programs: Excel, Word, Power Point and Outlook.
• Advanced knowledge in Computers (skilled in management / medium-advanced transcription)
• Bilingual (Spanish and English). Reading ability to write and speak in both languages at an intermediate/advanced level.
• Good knowledge of DEA requirements and procedures.
• Highly analytical with strong attention to detail.
• Ability to research data from multiple sources to perform investigation work.
• Skill in interpreting regulations, rule, and law.
• Ability to gather information, analyze and identify factors related to the investigation process.
• Ability to read, analyze and translate common technical and scientific publications, financial reports, and legal documents.  Ability to respond to questions and complaints from customers, regulatory agencies, or members of the business community.  Ability to write speeches and articles to be published and conform to the prescribed style and format.  Ability to effectively present information to management and public groups.