Controlled Substances Program Officer

Role Overview

• Serves as the subject matter expert (SME) and program co-lead for the College of Medicine Office of Research Controlled Substances Program (COM CSP).
• 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.
• Implements and oversees COM CSP development and enterprise-wide projects including the rollout and optimization of 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.
• Advises on policy and training programs; ensures continuous improvement in COM CSP scalability.
• May mentor and train junior team members.

Requirements

• 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.
• 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.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.