Research Regulatory Manager, Research, UofL Health, Days

UofL Health•Louisville, KY

21d•Onsite

About The Position

UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and Brown Cancer Center. With more than 12,000 team members—physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals—UofL Health is focused on one mission: delivering patient-centered care to each and every patient each and every day. The Manager, Pharmacy Regulatory Compliance provides oversight of the development, implementation, and coordination of pharmacy led initiatives related to compliance with both accreditation standards as well as legal and regulatory compliance for the UofL Health system. The manager is responsible for oversight of the development of policies & procedures and related elements as well as educational programs to ensure staff compliance with accreditation and regulatory standards. This includes monitoring for controlled substance accountability to include use of surveillance software as well as manual audits. Responsibilities also include working with departments where medications are used to ensure compliance with medication use policy and regulatory standards.

Requirements

Graduated from an ACPE accredited College of Pharmacy (required)
Ten (10) years of hospital/health-system experience (required)
Three (3) years of pharmacy leadership experience (required)
Post-Graduate Year 1 (PGY-1) Pharmacy Residency required or three (3) years of relevant work experience (required)
Extensive knowledge of state and federal drug statutes (required)
Extensive knowledge of Joint Commission accreditation standards (required)
Licensed or license eligible as a pharmacist in the Commonwealth of Kentucky (required)
Current board certification by Board of Pharmacy Specialties® within area of expertise (if available) or must obtain within two (2) years from date of hire (required)

Responsibilities

Directs effective, system-wide quality assurance program for pharmacy regulatory compliance
Ensures that policies for prescribing, communicating, preparing, dispensing, administering, and monitoring medication therapy meet all applicable regulatory requirements
Oversees coordination, consolidation, review and implementation of pharmacy policies and procedures
Oversees the identification, consolidation, revision, development, and implementation of medication use policies and procedures
Develops and maintains current Joint Commission accreditation education and training materials and widely distribute; provides timely and effective training sessions to prepare staff for accreditation and to ensure a constant state of readiness
Conducts quarterly gap analyses in pharmacies and patient care areas for compliance with standards, rules, and regulations and assesses potential organizational impact; develops and implement action plans to resolve any identified opportunities for improvement.
Contributes to the knowledge base of Pharmacy, Nursing, & Physician staff related to pharmacy regulations; ensures the competence of pharmacy and nursing staff and assists other pertinent staff in safe medication use practices, pharmacy policies and regulations
Manages data and report quarterly information related to medication use policies and regulations: Assesses and reports the status of efforts to improve medication-use policies and complies with regulations
Assesses hospital compliance with accreditation standards and with federal, state, and local regulations
Develops annual goals focused on meeting all regulatory compliance
Leads or coordinate controlled substance diversion investigations
Leads system-level pharmacy compliance with controlled substance policy compliance
Serves as the Chair of the Medication Use Policy Subcommittee
Serves as member of the System-wide Drug Diversion Committee
Supervises and leads other members of the Pharmacy Regulatory Compliance team to provide support to the UofL health system
Executes hospital and pharmacy policies and procedures
Assists with development and review of departmental policies and procedures
Functions as a role model and as an educational resource for pharmacy staff
Assists with related automated dispensing cabinet related issues to ensure legal and regulatory compliance
Promotes and demonstrates rational, cost-effective drug therapy
Ensures medication use policies promote rational, cost effective drug therapy
Facilitates and participates in scholarly and professional development activities
Provides guidance and supervision to certified pharmacy technicians
Precepts pharmacy students during IPPE and APPE rotations as necessary
Precepts PGY1 and PGY2 residents as necessary
Participates in staff development (preceptor development/continuing education) for all pharmacy learners within area of expertise
Actively participates in local, regional, or national organizations in area of expertise encouraged
Collaborates with pharmacy leadership in developing education, training, and competency programs
Designs and delivers didactic lectures to nursing orientation, Colleges of Pharmacy, Nursing and/or Medicine
Assists in recruitment and orientation of new staff members
Effectively Communicates
Utilizes advanced communication skills to convey and demonstrate expertise
Forms collaborative relationships with pharmacy team members and other members of the healthcare team
Demonstrates effective professional communications including articulation of recommendations
Demonstrates the ability to work in team environment, reaffirming the contribution of each person to the delivery of care/services
Maintains involvement in pharmacy department or hospital committees
Achieves and maintains satisfactory working relationships with pharmacy leadership, pharmacy staff and other departments throughout the system, including committees and administration
Attends departmental staff meetings
Exhibits Initiative and Judgment
Demonstrates self-motivation and the ability to work independently
Demonstrates stewardship in the performance of daily operations through accuracy of work and compliance with regulations
Participates collegially in the development of new programs, services and practices, in the education activities of the department
Maintains awareness of contemporary trends in area of expertise and the profession through professional literature
Maintains compliance with all company policies, procedures and standards of conduct
Complies with HIPAA privacy and security requirements to maintain confidentiality at all times
Performs other duties as assigned