The Ohio State University College of Medicine needs to ensure its Controlled Substances Program (COM CSP) meets all regulatory requirements from the DEA, State of Ohio Board of Pharmacy, University, and COM. This involves designing, implementing, and evaluating compliance frameworks, leading program development, and optimizing technology platforms to mitigate regulatory risks.
Requirements
- Bachelor’s degree or equivalent experience.
- 4 years’ experience (4-8 preferred) in a regulatory compliance, auditing, or regulatory affairs capacity in a research, government, or healthcare setting.
- Demonstrated expertise in controlled substances regulations, narcotics/pharmaceutical management, and research compliance.
- Proven experience leading cross-functional initiatives, developing protocols and SOPs, and implementing compliance systems.
- Advanced degree in regulatory affairs, compliance, public health, pharmacy, or related field.
- Experience with DEA/BOP inspections, federal and state licensing processes, and vendor management.
- Expertise in laboratory inspection programs and internal auditing methods.
Responsibilities
- Designs, implements, and evaluates research compliance frameworks to ensure the COM CSP meets U.S. Department of Justice Drug Enforcement Administration (DEA), State of Ohio Board of Pharmacy (BOP), University and COM requirements.
- Leads program development and enterprise-wide projects including the rollout and optimization of technology platforms such as Vestigo Pre-Clinical, and Environmental Health and Safety (EHS) Assist, development of standard works, process documents, web page development, researcher guidance, and development of high-impact metrics and reporting.
- Leads DEA and BOP research laboratory inspections and develops internal inspection and monitoring strategies to proactively identify and mitigate regulatory compliance risks.
- Provides strategic consultation to investigators and research teams and collaborates with institutional partners including Office of Legal Affairs, EHS, Office of Research Compliance, Investigational Drug Service, The James Inpatient Pharmacy, internal and external suppliers.
- Serves as the primary regulatory liaison and compliance advisor for COM CSP operations.
- Advises the University on policy and training programs; ensures continuous improvement in research compliance and program scalability.
- May mentor and train junior COMOR-C team members.
Other
- Bachelor's Degree or equivalent experience
- Final candidates are subject to successful completion of a background check.
- A drug screen or physical may be required during the post offer process.
- The university is an equal opportunity employer, including veterans and disability.
- Active certification(s) preferred: CPhT, RPhT, CPIA, or equivalent.
