Pharmacy Regulatory Coord

Summary

**This position requires on‑site presence and is not a remote role**

This role provides ongoing monitoring support to assure regulatory compliance with current and future regulations for all MyMichigan Health outpatient pharmacies.

Responsibilities

• (20%) * Performs ongoing monitoring activity to ensure regulatory integrity and compliance. Areas of over site include but are not limited to; DEA, State and Federal law, Licensing, State Board of Pharmacy, ACHC, USP (797 and 800), FDA, OSHA, DSCSA and payer regulations.
• (15%) * Ensures pharmacy compliance with: all State and Federal laws and applicable regulations, health system policies, accreditation standards.
• (15%) * Works with the pharmacist that oversees regulatory compliance at each site on the resolution of discrepancies and issues. Notifies the pharmacist and pharmacy administration of all unresolved discrepancies or issues.
• (10%) * Maintains external audit readiness. Participates in internal audits from MyMichigan Health and any external regulatory agencies. (10%) * Analyzes and provides periodic reports of monitoring activity and issues resolution.
• (10%) * Helps keep contracts and other regulatory requirements up to date and renewed by deadlines. Examples include pharmacy and personnel licenses, NCPDP, PSE certification, immunization certifications and insurance credentialing.
• (5%) * Helps develop training, educational materials and policies and procedures needed for regulatory compliance.
• (5%) * Actively seeks information from DEA, USP, or other resources to stay current with program changes, regulations and new guidance.
• (5%) * Coordinates department-specific Performance Improvement activities and reports to the Pharmacy manager, organizational wide Performance Improvement coordinator or other group as necessary.
• (5%) * Attends, participates and helps lead the Quality Management Committee and regulatory compliance committee meeting.
• Maintain current knowledge on evolving regulatory and industry standards in the pharmacy landscape that are relevant to our business model and communicate updates to appropriate team members.
• Perform an annual pharmacy risk analysis and develop compliance programs to ensure timely corrective/preventative actions are executed.
• This role requires frequent collaboration and coordination with support departments and governing bodies- HIPAA Privacy Officer, compliance team members, legal, DEA, FDA, state and federal law, board of pharmacy.
• Manages requests received from vendors, members, states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM) and other regulatory authorities relating to regulatory compliance initiatives, licensing, and related processes.
• Manages workflow and the compliance audit process to ensure that compliance audits are completed timely and in agreement with states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM), and other vendor requirements.
• Acts as an internal liaison to support states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM), and other vendor audits.
• This role is also responsible for ensuring all administrative tasks related to pharmacy compliance are appropriate and up to date with current requirements, including reporting and record keeping duties, programs, exclusion checks, pharmacy and pharmacist licensure maintenance and all applicable training
• Contracting and re-credentialing with PBMs and other contracts as needed.
• Other regulatory projects as needed and assigned.
• May require travel to other MyMichigan Health locations.
• Certifications and Licensures
• Required: PHARM TECH: Pharmacy Technician Licensure
• Equivalent Experience: Effective October 1, 2015, all incumbents, new hires and transfers to this position must possess a valid pharmacy technician license through the state of Michigan. The pharmacy technician license must be maintained in order to be qualified to hold this position.
• Required Education
• High School Diploma or GED
• Equivalent Experience: Associate degree or higher preferred.
• Other Information
• EXPERIENCE, TRAINING AND SKILLS: Extensive working knowledge of pharmacy information systems, financial systems, inventory systems, dispensing applications / hardware, reporting tools, office applications.
• Knowledge of auditing systems preferred.
• Mathematical skills needed to complete simple calculations as required by the position.
• Interpersonal skills needed to communicate successfully with individuals and groups and interact with people at all levels to communicate ideas and concepts in a clear and understandable manner.
• MyMichigan Health is a technology driven organization and employees need to demonstrate competency in Microsoft Windows. An employee may be required to participate in further learning opportunities offered by MyMichigan Health.
• Hospital or medical center pharmacy experience preferred.
• Understanding of the Pharmacy industry
• Ability to work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently.
• Proven leadership, assertiveness, interpersonal and analytical skills proficiency is essential.
• Well-developed oral and written communication skills including the ability to write and deliver both informal and formal presentations.
• Ability to prepare clear, concise documents for general and technical needs.
• Strong computer skills: proficient in MS Office
• Previous experience in a retail setting preferred.
• PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS: Exposure to stressful situations, including those involving public contact, as well as trauma, grief and death.
• Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.
• Can move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.
• Overall vision and hearing are necessary with or without assisted device(s).
• Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling, or crouching.
• Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.
• Ability to handle multiple tasks, get along with others, work independently, regular, and predictable attendance and ability to stay awake.
• Overall dexterity is required including handling, reaching, grasping, fingering, and feeling. May require repetition of these movements on a regular to frequent basis.
• Physical Demand Level: Light.
• Must be able to occasionally (0-33% of the workday) lift or carry 11-20 lbs., frequently (34-66% of the workday) 10 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls.
• Equivalent Experience and Other Comments (Education)
• Other Comments
• #Indeed1HP

Responsibilities

• (20%) * Performs ongoing monitoring activity to ensure regulatory integrity and compliance. Areas of over site include but are not limited to; DEA, State and Federal law, Licensing, State Board of Pharmacy, ACHC, USP (797 and 800), FDA, OSHA, DSCSA and payer regulations.
• (15%) * Ensures pharmacy compliance with: all State and Federal laws and applicable regulations, health system policies, accreditation standards.
• (15%) * Works with the pharmacist that oversees regulatory compliance at each site on the resolution of discrepancies and issues. Notifies the pharmacist and pharmacy administration of all unresolved discrepancies or issues.
• (10%) * Maintains external audit readiness. Participates in internal audits from MyMichigan Health and any external regulatory agencies. (10%) * Analyzes and provides periodic reports of monitoring activity and issues resolution.
• (10%) * Helps keep contracts and other regulatory requirements up to date and renewed by deadlines. Examples include pharmacy and personnel licenses, NCPDP, PSE certification, immunization certifications and insurance credentialing.
• (5%) * Helps develop training, educational materials and policies and procedures needed for regulatory compliance.
• (5%) * Actively seeks information from DEA, USP, or other resources to stay current with program changes, regulations and new guidance.
• (5%) * Coordinates department-specific Performance Improvement activities and reports to the Pharmacy manager, organizational wide Performance Improvement coordinator or other group as necessary.
• (5%) * Attends, participates and helps lead the Quality Management Committee and regulatory compliance committee meeting.
• Maintain current knowledge on evolving regulatory and industry standards in the pharmacy landscape that are relevant to our business model and communicate updates to appropriate team members.
• Perform an annual pharmacy risk analysis and develop compliance programs to ensure timely corrective/preventative actions are executed.
• This role requires frequent collaboration and coordination with support departments and governing bodies- HIPAA Privacy Officer, compliance team members, legal, DEA, FDA, state and federal law, board of pharmacy.
• Manages requests received from vendors, members, states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM) and other regulatory authorities relating to regulatory compliance initiatives, licensing, and related processes.
• Manages workflow and the compliance audit process to ensure that compliance audits are completed timely and in agreement with states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM), and other vendor requirements.
• Acts as an internal liaison to support states Board of Pharmacy, Drug Enforcement Agency (DEA), Pharmacy Benefit Manager (PBM), and other vendor audits.
• This role is also responsible for ensuring all administrative tasks related to pharmacy compliance are appropriate and up to date with current requirements, including reporting and record keeping duties, programs, exclusion checks, pharmacy and pharmacist licensure maintenance and all applicable training
• Contracting and re-credentialing with PBMs and other contracts as needed.
• Other regulatory projects as needed and assigned.
• May require travel to other MyMichigan Health locations.

Qualifications

• EXPERIENCE, TRAINING AND SKILLS: Extensive working knowledge of pharmacy information systems, financial systems, inventory systems, dispensing applications / hardware, reporting tools, office applications.
• Knowledge of auditing systems preferred.
• Mathematical skills needed to complete simple calculations as required by the position.
• Interpersonal skills needed to communicate successfully with individuals and groups and interact with people at all levels to communicate ideas and concepts in a clear and understandable manner.
• MyMichigan Health is a technology driven organization and employees need to demonstrate competency in Microsoft Windows. An employee may be required to participate in further learning opportunities offered by MyMichigan Health.
• Hospital or medical center pharmacy experience preferred.
• Understanding of the Pharmacy industry
• Ability to work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently.
• Proven leadership, assertiveness, interpersonal and analytical skills proficiency is essential.
• Well-developed oral and written communication skills including the ability to write and deliver both informal and formal presentations.
• Ability to prepare clear, concise documents for general and technical needs.
• Strong computer skills: proficient in MS Office
• Previous experience in a retail setting preferred.
• PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS: Exposure to stressful situations, including those involving public contact, as well as trauma, grief and death.
• Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.
• Can move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.
• Overall vision and hearing are necessary with or without assisted device(s).
• Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling, or crouching.
• Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.
• Ability to handle multiple tasks, get along with others, work independently, regular, and predictable attendance and ability to stay awake.
• Overall dexterity is required including handling, reaching, grasping, fingering, and feeling. May require repetition of these movements on a regular to frequent basis.
• Physical Demand Level: Light.
• Must be able to occasionally (0-33% of the workday) lift or carry 11-20 lbs., frequently (34-66% of the workday) 10 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls.