The University of Virginia is seeking a compliance professional to establish institutional processes, streamline existing methods, and manage primary components of the Institutional Controlled Substances (CS) Program drugs, precursors, and other materials subject Drug Enforcement Agency (DEA) and Virginia Board of Pharmacy (VBP) regulations and licensing. The scope of the CS Program is research uses of controlled substances and explicitly excludes clinical care and other non-research programs that may involve controlled substances.
Position Location: Expectation is that this position will primarily work in an on UVA Grounds office environment, with limited remote work potential. Individual will be required to regularly visit laboratories across Grounds for individual outreach, meetings, monitoring visits and inspections.
This position will be responsible for providing oversight of the CS Program to ensure compliance with state and federal CS regulations as well as applicable institutional policies and procedures, including those pertaining to animal welfare regulations and requirements (e.g., US Department of Agriculture, Public Health Service Policy, Guide for the Care and Use of Laboratory Animals, and the Food and Drug Administration).
Manage Federal and State Researcher Registration application, modification, and closeout processes; advise and assist registrants throughout the lifetime of their registrations; and serve as Certifying Official for employment verifications.
Develop or improve policies, procedures, required documentation (logs, forms), guidance, and communications regarding the use of CS in research.
Develop and maintain CS program website and database(s) of registrations, monitoring visits, compliance, inspections, etc. and generate reports as needed.
Improve existing or develop new training content and deliver (required and recommended) and retraining, as needed, to Registrants and Authorized Users
Provide outreach material for potential and current Registrants and Authorized Users
Conduct monitoring visits (for cause, routine, and pre-inspection) to review registrations, procurement, recordkeeping, handling, storage, waste and disposal of CS to ensure compliance with state and federal CS regulations.
Review inspection/deficiency reports, evaluating proposed corrective action plans, assist with the formulation of institutional responses and confirm resolution of deficiencies.
Audit CS notebooks (recordkeeping) for compliance (usage, disposal, AU’s)
The CS Program Manager is expected to meet regularly with registrants and other stakeholders. The position must work collaboratively with other UVA offices (e.g., Animal Care and Use, Finance, Center for Comparative Medicine, Office of Animal Welfare, Environmental Health and Safety, and the Research Pharmacy) and stakeholders to streamline and facilitate institutional processes and procedures such as CS ordering, delivery, waste and disposal, including reverse distribution, while assuring ongoing compliance with all applicable requirements.
The CS Program Manager will serve as the primary institutional liaison with state and federal CS agencies for Registrant inspections, deficiency reports, and institutional response(s); assist with scheduling DEA/VBP inspections; escort inspectors on inspections of Research Registrant areas.
The successful candidate must meet eligibility requirements for DEA and VBP Registrants but need not currently hold or have held such registration. The successful candidate will have demonstrated excellent oral and written communications skills. Strong organizational skills, attention to detail, and proficiency in the use of standard office software will be essential for success in this position.
Education: Bachelor's degree in relevant subject required. Advanced degree in relevant subject area strongly preferred.
Experience: At least five years of relevant experience. In depth knowledge of federal (DEA) and state (VBP) regulations is strongly preferred. Experience developing, implementing, or managing a regulatory compliance program strongly preferred. Familiarity with the use of controlled substances in animal research within an academic institution and knowledge of associated compliance requirements and animal welfare regulations is preferred.
Please apply online, and search for R0056833. Internal applicants must apply through their UVA Workday profile by searching ‘Find Jobs.’ Complete an application online with the following documents:
Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration. This position is open until filled.
References will be completed via UVA’s standardized process SkillSurvey. A total of five references will be requested via SkillSurvey during the final phase of the interview process. A minimum of three is required.
For information regarding the position or the application process, please contact Jessica Speth, Academic Recruiter, firstname.lastname@example.org.