Pharmacy Specialist - Regulatory Affairs Elijah McCoy Detroit

Become part of Henry Ford Health as a full time Pharmacy Specialist - Regulatory Affairs
, playing a key role in advancing system wide pharmacy compliance. This individual will serve as the enterprise expert for pharmacy regulatory affairs, supporting both the clinical delivery system and shared services across Henry Ford Health. This position is based out of our Detroit Elijah McCoy Campus.

Schedule:

Full Time - 40 hours a week

Location:

Detroit, MI - Elijah McCoy Campus

This pharmacist specialist position serves as the enterprise subject-matter expert for pharmacy regulatory affairs & compliance across Henry Ford Health s clinical delivery system and shared services.

• This role is responsible for supporting regulatory readiness, accreditation compliance, operational and policy alignment across the High-Value Pharmacy Enterprise (HVPE) pharmacy operations.
• Maintain comprehensive knowledge of and ensure compliance with applicable CMS Conditions of Participation, Joint Commission standards, Michigan LARA, FDA, DEA, USP, and other federal, state, and accrediting-body requirements related to medication management.
• Act as the primary pharmacy liaison for regulatory surveys, inspections, audits, and accreditation activities impacting ambulatory clinics, infusion services, and centralized pharmacy services. Also, it serves as supporting pharmacy liaison for HFH hospitals.
• Coordinate pharmacy preparation for external surveys; lead pharmacy response, corrective action planning, and sustained compliance monitoring following findings or citations.
• Lead development, revision, and enterprise standardization of all pharmacy policies, procedures, and practice standards supporting regulatory & legal compliance and risk mitigation.
• Ensure pharmacy policies are current, version-controlled, communicated, and operationalized across all applicable sites.
• Serve as regulatory pharmacy subject-matter expert for the enterprise and lead the HVPE Pharmacy Regulatory Affairs Committee.
• Support and advise Medication Management Committee (MMC), MMC subcommittees, and related governance bodies on pharmacy regulatory implications of clinical and operational decisions.
• Design, oversee, and evaluate pharmacy regulatory audits, tracers, and compliance assessments across the enterprise.
• Trend findings, identify systemic gaps, and partner with operational leaders to drive sustainable corrective actions.
• Promote a constant state of readiness through education, mock surveys, targeted risk assessments, and proactive regulatory intelligence.
• Monitor emerging regulatory changes and assess enterprise impact, timelines, and implementation strategies.
• Provide regulatory interpretation, consultation, and guidance to pharmacy leaders, clinicians, and operational teams.
• Partner with Medication Safety, Quality, and Operations to ensure regulatory requirements are embedded into workflows, automation, and clinical practice models.
• Serve as the pharmacy point of contact for Michigan LARA and other regulatory agencies as applicable to clinical delivery operations.
• The pharmacist specialist works in close partnership with HVPE leadership, Quality & Safety, Accreditation Services, Legal, Compliance, and respective site operational leaders to translate requirements and opportunities into standardized pharmacy practice.
• "This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and duties. It should be understood, therefore, that employees may be asked to perform job-related duties beyond those explicitly described above."

• Must hold a degree from an accredited college of pharmacy and must complete a residency training program or have equivalent experience in hospital pharmacy practice.
• Minimum of 3-5 years of pharmacist experience or the equivalent training and experience at another institution, preferred.
• Working knowledge of pharmacy-related regulatory and accreditation requirements preferred.
• Experience with Joint Commission surveys, CMS compliance activities, regulatory audits, or accreditation readiness preferred.
• Experience in pharmacy policy development, compliance auditing, and quality improvement initiatives preferred.
• Certification in Pharmacy Accreditation & Regulatory Compliance by American Society of Health-System Pharmacists (ASHP) required within 6 months of hire.
• Must be able to serve as an institutional authority in a given specialty practice area.
• Must have demonstrable leadership abilities and exhibit teamwork when working with others.
• Must have excellent verbal and written communication skills which enable him/her to contribute effectively in the dissemination of information to all levels of health care personnel in the institution. Should have a proven research/publication record.
• Must be qualified to work with pharmacy students at the undergraduate and graduate levels.
• Must have a previous work history of…