We are recruiting for a HIGH LEVEL position in South Florida as Compliance Officer/Florida CDR. The ideal candidate will have FDA/DEA/499 and DSCSA experience. The salary range is in the mid $100's (negotiable) with full benefits. This is a rare position for the right person at a mid-sized established Drug Wholesaler.
Duties and responsibilities:
Under the direction of our President, the Compliance Officer will be responsible for developing, implementing, operating and monitoring in accordance with all applicable Federal and state laws, specifically in accordance with DEA, FDA, DSCSA and Florida Chapter 499, rules and regulatory requirements. The Compliance Officer shall function as an independent and objective body that reviews and evaluates compliance issues and concerns within the organization and produces corrective action plans. Accountability for audits of facilities and ensuring SOPs are followed and updated as required will be a critical component of the job.
This position will work to maintain, and continue to enhance the culture of compliance and behaviors across the enterprise.
- Manage the Compliance Program in accordance with all applicable Federal and state laws, specifically in accordance with DEA, FDA, DSCSA and Florida Chapter 499, rules, and regulatory requirements.
- Monitor and implement solutions to ensure compliance with applicable laws, rules and regulations, including, but not limited to, VAWD, NCDQS and other applicable accreditation programs for distributors.
- Establish and implement current and forward-looking compliance policy consistent with identified risk areas relative to industry standards.
- Ensure all applicable departments/functions are operating within SOP’s; update SOPs as required.
- Collaborate with departments such as President, Finance, Marketing Research, Product Management and HR, and direct compliance issues to appropriate channels for investigation and resolution.
- Remains current with developments of law, regulations, and corporate policy.
- Design, prepare, and deliver on-site compliance training for employees including preparation and distribution of training materials. Develop a training matrix.
- Monitor performance of the compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.
- Establish and manage an audit program including internal audits and facilitating audits by external organizations.
- Lead On-site audits at all facilities.
- Review business rules, documents, marketing materials and information to ensure compliance with regulatory agencies, federal and state laws.
- Respond to alleged violations of rules, regulations, policies, procedures, and the Code of Business Conduct by evaluating or recommending the initiation of investigative procedures.
- Understanding of Pharmaceutical Distribution, and repackaging experience is critical.
- Prior 3PL experience is helpful.
- BS/BA preferably in accounting, finance, business management, or a related field
- Regulatory background with the DSCSA, DEA, FDA and Florida Chapter 499
- Current CDR (Certified Designated Rep) or ability to test and acquire CDR within 12 months of date of hire.
- Record keeping, organizational skills.
- Prior pharmaceutical inventory experience
- Facility Audit Experience
- Experience writing SOP’s.
- Minimum of two years managerial experience