Controlled Substances Program Officer - Office of Research

About the role

The Controlled Substances Program Officer (CSPO) serves as the subject matter expert (SME) and program co-lead for the College of Medicine Office of Research Controlled Substances Program (COM CSP). The CSPO implements and evaluates regulatory 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 CSP requirements.

Responsibilities

• Implements and evaluates regulatory frameworks to meet DEA, BOP, university, and COM CSP requirements.
• Develops and oversees technology platforms such as CampusOptics, internal standard works, process documents, web page maintenance, researcher guidance, and high-impact metrics and reporting.
• Co-leads DEA and BOP research laboratory inspections and develops internal inspection and monitoring strategies to proactively identify and mitigate regulatory risks.
• Provides strategic consultation to researchers and collaborates with university partners including the Office of Legal Affairs, EHS, Office of Research Compliance, Investigational Drug Service, The James Inpatient Pharmacy, and internal and external suppliers.
• Serves as a primary regulatory liaison and advisor to the Senior Director, Research Strategy and Operations and the COM Responsible Person, in collaboration with COMOR-C.
• Advises on policy and training programs; ensures continuous improvement in COM CSP scalability.
• Mentors and trains junior team members.

Requirements

• Minimum Education Required: Bachelor’s degree or equivalent experience.
• Minimum Required Qualifications: Bachelor’s degree or equivalent experience. 4 years’ experience (4-8 preferred) in a regulatory affairs capacity within 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 processes and implementing regulatory systems.
• Additional Education Desired: Advanced degree in pharmacy, or related field.
• Required Qualifications: Experience with DEA/BOP inspections, federal and state licensing processes, and vendor management. Expertise in research laboratory inspection programs and internal inspection methods. Knowledge of federal and sponsor regulatory frameworks. Experience developing and overseeing operational compliance programs. Active certification(s) preferred: CPhT, RPhT, CPIA, or equivalent.

Qualifications

• Minimum Education Required: Bachelor’s degree or equivalent experience.
• Minimum Required Qualifications: Bachelor’s degree or equivalent experience. 4 years’ experience (4-8 preferred) in a regulatory affairs capacity within 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 processes and implementing regulatory systems.
• Additional Education Desired: Advanced degree in pharmacy, or related field.
• Required Qualifications: Experience with DEA/BOP inspections, federal and state licensing processes, and vendor management. Expertise in research laboratory inspection programs and internal inspection methods. Knowledge of federal and sponsor regulatory frameworks. Experience developing and overseeing operational compliance programs. Active certification(s) preferred: CPhT, RPhT, CPIA, or equivalent.