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Regulatory and Compliance Specialist Job
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| Employer Name: BRIGHT PHARMA INC dba BRIGHT AID PHARMACY |
SpiderID: 13976027 |
| Location: BRONX, New York |
Date Posted: 4/10/2025 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
Regulatory and Compliance Specialist is needed to perform the following duties:
o Responsible for REGULATORY COMPLIANCE leading to pharmacy management.
Evaluating and ensuring departmental and organizational policy and practice.
Chair the Pharmacy Performance Improvement and Regulatory Compliance requirement.
Compliance with applicable state and federal laws, rules and regulations, including but not limited to,
Fraud, waste and Abuse (FWA)
Centers for Medicare & Medicaid Services (CMS)
Drug Enforcement Agency (DEA)
Food and Drug Administration (FDA)
Health Insurance Portability and Accountability Act (HIPAA)
Develop compliance- related staff education programs and material upon frequent changes made to the regulatory bodies.
Working collaboratively with other pharmacy and organizational departments and managers to plan, coordinate and implement compliance improvement projects and programs for the pharmacy benefit.
Tracking data and creating reports to assist in the analysis of compliance and safety issues including but not limited to ongoing regulatory monthly inspections, tracers, adverse event reporting, core measures and other accountability measures
Develop compliance-related staff education programs and materials upon frequent changes made to the regulatory bodies.
Conduct in-depth compliance monitoring of key operational areas related to Medicare Pare D and assist with conducting Medicare Part D compliance meetings.
Track data and creates reports to assist in the analysis of compliance issue patterns.
Work on medication therapeutic management- track medication adherence for aged patient and educate them about medication adherence for better health.
Oversees and documents external regulatory investigations and audits related to pharmacy, durable medical equipment, and retail operations compliance.
Monitors, analyzes, interprets, and communicates regulatory changes related to pharmacy and durable medical equipment.
o Participation in reviewing patient complaints for Medication safety and Patient awareness for Health.
Co-ordination of a consistent and timely approach to medication-related event review and follow-up (in conjunction with the pharmacy patients and providers), under the direction of Medication Safety tips provided by MTM analysis, ensuring accurate documentation of root cause analysis and its Therapy management
Conducting Medication Therapy Management Program (MTM) and Mirixa healthcare services providing bridge between pharmacy performances and Patient health assessment.
Work with supervising pharmacist to investigate suspected employee misconduct and determine appropriate discipline for employees found to have committed compliance violations.
Coordinates and arranges for the receipt of complaint samples and medical records from reporter/complainant/ hospitals, medical facilities/pharmacies, etc.
Interpret and apply DEA, FDA and other state and federal regulations to business practices and provide regulatory input, advice, and guidance to the organization.
o Monitoring, analyzing, interpreting and Communicating regulatory changes by utilizing available resources from regulatory organizations:
Job duties including periodical meetings with Pharmacy staff and pharmacist to keep tract for ongoing process of the pharmacy operation in order to comply with current regulation requirements.
Prepare the implementation of strategic plan with Gantt chart for the task to perform vs. duration of time
o Provide the required State, Federal, Medicaid and Medicare Laws compliance support and lead in DEA Regulations. Respond to complaints from the state, OIG complains, state inspections, PDMP, DEA Inspection findings, Insurance audit findings and its response.
Attending the insurance audits and providing them the necessity documents as proof of compliance with regulatory requirements.
Responding on the audit findings by submitting the missing documents, to justify the claim discrepancies and amount deduction applied to the pharmacy
Checking the PDMP website prior to dispensing the controlled Rxs and submission of the claims to the PDMP website through prime Rx system (Electricals claim submission vendor) on daily bases in order for the regulatory bodies to find discrepancies in claim submission or overuse of opioid medicine by patient.
Resolve the discrepancies findings responded by PDMP software.
OIG complain handling, state inspection handling by submitting current employees information including HIPAA and FWA certification, employee criminal background checking, Technician Protocol submission, OIG exclusion verification page, the e-signature logs for Rxs through the system software, copies of Rxs required by the auditors and all the regulatory policy and procedure related to the regulations of the Pharmacy.
Keep updates with new compliance requirements and review the compounding of the prescriptions looking for discrepancies, if any in what being dispenses and the prescription provided by the Physician.
Execute the strategic and compliance plans for the company, with particular emphasis on achieving overall profitability with sales and future expansion.
Responsible for the development and implementation of maintaining compliance standards with a focus on rapid development, flexibility, financial integrity, bottom line results, coordinating logistic, regulatory affairs and implementation strategy.
To assist the pharmacist to reduce potential of regulatory and compliance dispensing errors.
o Lead the research of the pharmacy Department through Development of automated processes and reporting, targeted to improve efficiency and ensure compliance of health plan policy/procedures and regulatory standards
Monitors regulatory activity and rulemaking through weekly interaction with NACDS, FMI, and state organizations
Online subscription of government regulated bodies including Medicare, Medicaid, State Federal, DEA, HIPAA and FWA newsletter etc. in order to get automatic update regarding the new law implementation or change in any existing laws and regulations.
Coordinating creation and updates of Department of Pharmacy policies & procedures
Ensure timely signature and posting to intranet page
Business continuity disaster recovery
o Responsible for medication inventory-the DEA regulations compliance including bringing together the documentation of expired controlled substance and the inventory management of control substance consistent with the strategic plan of the company.
Assist in maintain the inventory record of CII, CIII, CIV and CV drugs
Review and assist pharmacists with DEA-106 forms for loss or theft of federal controlled substances.
Assist the employee in recall medication and its return procedure
Updating Inventories for regular and controlled medicines every 6 month and assist in returning of the medication through legal way.
Develop marketing strategies and track the outcomes periodically.
Bachelors degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: BRIGHT PHARMA INC dba BRIGHT AID PHARMACY |
Company Type: Employer |
| Company: BRIGHT PHARMA INC dba BRIGHT AID PHARMACY |
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| City: Bronx |
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| State: New York |
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| Zip: |
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