Controlled Substances Program Officer - Office of Research

Controlled Substances Program Officer - Office of Research Job Title: Controlled Substances Program Officer – Office of Research Department: Medicine | Office of Research Administration Overview Under the direction of the Senior Director, Research Strategy and Operations, the Controlled Substances Program Officer (CSPO) serves as the subject matter expert 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 compliance with DEA, BOP, university, and COM CSP requirements. The CSPO implements and oversees COM CSP development and enterprise‑wide projects including 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. The CSPO 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. May mentor and train junior team members. Responsibilities Implement and evaluate regulatory frameworks to ensure compliance with DEA, BOP, university, and COM CSP requirements. Oversee COM CSP development and enterprise‑wide projects including 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‑lead DEA and BOP research laboratory inspections and develop internal inspection and monitoring strategies to proactively identify and mitigate regulatory risks. Provide strategic consultation to researchers and collaborate 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. Act as primary regulatory liaison and advisor to the Senior Director, Research Strategy and Operations and the COM Responsible Person, in collaboration with COMOR-C. Advise on policy and training programs; ensure continuous improvement in COM CSP scalability. May mentor and train junior team members. Minimum Education Required Bachelor’s degree or equivalent experience. Minimum Required Qualifications Bachelor’s degree or equivalent experience. 4 years (4‑8 preferred) of experience in a regulatory affairs capacity within 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. Function & Sub‑Function Function: Research Administration Sub‑Function: Research Compliance Career Level: S3 Additional Information Location: Hamilton Hall (0038) Position Type: Regular Scheduled Hours: 40 Shift: First Shift Background Check Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post‑offer process. Equal Opportunity The university is an equal opportunity employer, including veterans and disability. #J-18808-Ljbffr The Ohio State University