Regulatory Affairs Specialist

Regulatory Affairs Specialist 130 State Route 33 Ste 6, Manalapan, NJ 07726 $52,051.12 - $65,000.00 a year - Part-time $52,051.12 - $65,000.00 a year - Part-time Regulatory and Compliance Analyst is needed to perform the following duties: "Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science "

Job Duties:

Ability in helping pharmacist in reviewing prescription claims including Medicaid, Medicare and all other third party insurance companies. Contributing the required support in Laws compliance and in DEA regulations as per the State, Federal, Medicaid and Medicare. Assisting pharmacist in addressing the audit findings by pulling out the any missing documentation related to the prescription claims audits. Actively participating in organising Medication Therapy Management (MTM) sessions and Mirixa health care services in order to enhance the medication adherence for improving pharmacy star-rating. Helping in running periodic report file to ensure Prescription Drug Monitoring program (TX PMP) in order to screen potential drug abuse/illegal activity along with automated submission to TX board of Pharmacy & DEA. Abiding HIPPA regulations strictly with respective to the timeframes and monitoring OIG checklist for both employees and vendors and stating the exclusion list if it is applicable as per the regulations. Monitoring Standard operational procedures related to all classes of prescriptions dispensing and making sure all the storage conditions pertaining to Refrigerator Temperature logs, controlled substance storage complies with the standard indications as per SOP's. Actively participating in the maintenance of inventory record of all class of controlled substances and reviewing applicable laws for any loss or theft of controlled substances. Periodically updating the inventories twice a year making sure if the inventory has to be returned legally in a defined way for both regular and controlled medicines as well. In-depth monitoring of all key compliance factors and organising meetings in regards to Medicare Part D Making sure to follow protocols for DAW (Dispense As Written) codes with relates to state legislature. Addressing various complaints from state and Federal regulatory agencies, Insurance audit findings and its response in a stipulated time period. Ensuring accurate documentation of RCA in response to medication-related event. Subscribing to government regulated authorities including Medicare, Medicaid, State Federal, DEA, HIPAA and FWA newsletter etc. to get updates regarding any new law implementations or changes in any existing laws and regulations. Active participation in pharmacy team meetings for updates in all ongoing pharmacy operations to comply with regulation requirements.

Job Type:

Part-time Pay:

$52,051.12 - $65,000.00 per year

Education:

Bachelor's (Preferred)

Experience:

State, Federal and FDA regulations: 3 years (Required) Pharmacy software: 3 years (Required) certified Pharmacy technician: 3 years (Preferred)

Work Location:

In person