Director of 340B Compliance- *MUST HAVE ACE Certification**
Onsite- Winter Park, FL
Job Summary Position oversees all aspects of the 340B Drug Pricing Program and Internal Administration Platform’s strategic and operational compliance activities, ensuring that the organization maintains continual compliance with all federal regulations and program requirements. Role serves as the accountable agent of 340B compliance, oversees day-to-day compliance operations, conducts regular internal audits, and ensures the program is leveraged to maximize eligible savings. Position advises new and changing regulations, leads policy development, collaborates with interdisciplinary teams, and communicates findings to organizational leadership, acting as the primary subject expert and authority for the 340B program.
Job Purpose Position ensures the organization’s full compliance with all federal 340B program rules, policies, and reporting requirements by managing and directing all aspects of the program’s participation in the 340B program—protecting program integrity, preventing medication diversion, maximizing eligible drug purchasing discounts and minimizing compliance risk. Position is accountable for ongoing eligibility, conducting internal audits, updating policies in response to regulatory changes, and keeping leadership informed on compliance status while providing expert guidance to all personnel involved in the 340B program medication procurement and billing processes.
Essential Functions Essential functions are the primary duties/main job responsibilities that an incumbent must be able to perform, with or without accommodation. Key accountability areas include regulatory compliance, policy development and implementation, monitoring and auditing, operational management, and reporting and communication.
Job Factors Minimum Education Level Required: Bachelor’s degree in pharmacy, healthcare administration, business, or a closely related field. Advanced degree (PharmD, MBA, MHA) preferred. Apexus certification (ACE) required. Minimum Experience Level Required: Minimum five years of direct experience in 340B program administration, drug pricing compliance or related healthcare regulatory role. Minimum three years hands-on supervisory or personnel management experience in a pharmacy or healthcare setting.
Knowledge, Skills and Abilities Expert level understanding of 340B Drug Pricing Program federal regulations, HRSA/OPA guidance, pharmacy operations and compliance best practices. Working knowledge of healthcare administration, billing processes, and relevant software systems. Demonstrated familiarity with medication diversion and duplicate discount prevention strategies, policies, and audit processed. Leadership experience managing cross-functional operational teams within a healthcare, pharmacy or related complex regulatory environment. Demonstrated knowledge of 340B Drug Pricing Program regulations, federal compliance requirements, and HRSA guidelines. Exceptional written and verbal communication skills with the ability to communicate effectively with all levels of the organization and adapt messaging for the appropriate audience. Advanced analytical skills for data interpretation, program auditing and identification of compliance risks. Ability to function in a complex team environment, collaborating with external and internal professionals and other customers. Self-directed and self-motivated, demonstrated ability to meet deadlines and manage competing demands efficiently and simultaneously. Strong organizational and project management skills to oversee program activities, audits, and reporting deadlines. Computer skills (word processing, spreadsheets, databases) and familiarity with various software programs, equipment and technology necessary to provide 340B pharmacy services. Familiarity with PioneerRx, eClinicalWorks or other 340B platforms preferred. Exceptional time management, decision-making and organizational skills and abilities. Strong interpersonal relationship skills, professionalism and high emotional intelligence. Ability to work independently as well as part of a team, manage multiple priorities, and build relationships. Ability to ensure a high level of customer satisfaction including employees, patients, physicians and stakeholders.
Work Environment Physical Demands The physical demands described represent those that an employee must meet in order to perform the essential functions of the job. Reasonable accommodation may be made in compliance with the Americans with Disabilities Act of 1990. High mobility, prolonged standing and walking, sometimes for extended periods without breaks. High manual dexterity and repetitive movements using hands and fingers. Motor vehicle and other transportation operations between campus locations and to off-campus locations and events (Travel 10%) Lifting items up to 30 pounds and physical exertion. Frequent bending, stretching, twisting and reaching. Access information using a computer
Job Summary Position oversees all aspects of the 340B Drug Pricing Program and Internal Administration Platform’s strategic and operational compliance activities, ensuring that the organization maintains continual compliance with all federal regulations and program requirements. Role serves as the accountable agent of 340B compliance, oversees day-to-day compliance operations, conducts regular internal audits, and ensures the program is leveraged to maximize eligible savings. Position advises new and changing regulations, leads policy development, collaborates with interdisciplinary teams, and communicates findings to organizational leadership, acting as the primary subject expert and authority for the 340B program.
Job Purpose Position ensures the organization’s full compliance with all federal 340B program rules, policies, and reporting requirements by managing and directing all aspects of the program’s participation in the 340B program—protecting program integrity, preventing medication diversion, maximizing eligible drug purchasing discounts and minimizing compliance risk. Position is accountable for ongoing eligibility, conducting internal audits, updating policies in response to regulatory changes, and keeping leadership informed on compliance status while providing expert guidance to all personnel involved in the 340B program medication procurement and billing processes.
Essential Functions Essential functions are the primary duties/main job responsibilities that an incumbent must be able to perform, with or without accommodation. Key accountability areas include regulatory compliance, policy development and implementation, monitoring and auditing, operational management, and reporting and communication.
Job Factors Minimum Education Level Required: Bachelor’s degree in pharmacy, healthcare administration, business, or a closely related field. Advanced degree (PharmD, MBA, MHA) preferred. Apexus certification (ACE) required. Minimum Experience Level Required: Minimum five years of direct experience in 340B program administration, drug pricing compliance or related healthcare regulatory role. Minimum three years hands-on supervisory or personnel management experience in a pharmacy or healthcare setting.
Knowledge, Skills and Abilities Expert level understanding of 340B Drug Pricing Program federal regulations, HRSA/OPA guidance, pharmacy operations and compliance best practices. Working knowledge of healthcare administration, billing processes, and relevant software systems. Demonstrated familiarity with medication diversion and duplicate discount prevention strategies, policies, and audit processed. Leadership experience managing cross-functional operational teams within a healthcare, pharmacy or related complex regulatory environment. Demonstrated knowledge of 340B Drug Pricing Program regulations, federal compliance requirements, and HRSA guidelines. Exceptional written and verbal communication skills with the ability to communicate effectively with all levels of the organization and adapt messaging for the appropriate audience. Advanced analytical skills for data interpretation, program auditing and identification of compliance risks. Ability to function in a complex team environment, collaborating with external and internal professionals and other customers. Self-directed and self-motivated, demonstrated ability to meet deadlines and manage competing demands efficiently and simultaneously. Strong organizational and project management skills to oversee program activities, audits, and reporting deadlines. Computer skills (word processing, spreadsheets, databases) and familiarity with various software programs, equipment and technology necessary to provide 340B pharmacy services. Familiarity with PioneerRx, eClinicalWorks or other 340B platforms preferred. Exceptional time management, decision-making and organizational skills and abilities. Strong interpersonal relationship skills, professionalism and high emotional intelligence. Ability to work independently as well as part of a team, manage multiple priorities, and build relationships. Ability to ensure a high level of customer satisfaction including employees, patients, physicians and stakeholders.
Work Environment Physical Demands The physical demands described represent those that an employee must meet in order to perform the essential functions of the job. Reasonable accommodation may be made in compliance with the Americans with Disabilities Act of 1990. High mobility, prolonged standing and walking, sometimes for extended periods without breaks. High manual dexterity and repetitive movements using hands and fingers. Motor vehicle and other transportation operations between campus locations and to off-campus locations and events (Travel 10%) Lifting items up to 30 pounds and physical exertion. Frequent bending, stretching, twisting and reaching. Access information using a computer