Overview

Join a growing company!!!

At Knipper, our most valuable resource is our people. Our employees are what differentiate us most from our competition.

We want every Knipper employee to be successful in their career, to learn and grow, and to be well compensated for their efforts.

Family-culture! Supportive team! 

Impact a patient’s life!

Our vision is to CREATE THE SHORTEST PATH BETWEEN PATIENT AND THERAPY.

The Compliance Analyst is responsible for supporting the daily operations of the Regulatory Compliance department. The Compliance Analyst operates primarily at the tactical level, but is required to know and understand cGMP, PDMA, DEA, HIPAA, and Part 11 regulatory requirements in order to effectively support company compliance activities on a day-to-day basis and in support of sample accountability, warehousing and distribution of pharmaceutical products.

Responsibilities

• Execute needed deliverables such as client requests, internal compliance queries and agency requests in a timely and efficient manner.• Research and analyze regulations and laws relevant to Knipper operations and client programs to alert Regulatory Affairs and Compliance management to review, evaluate potential impact to compliance of these regulatory and legal requirements.• Assist Regulatory Affairs and Compliance management with projects and follow up, as needed.• Collaborate with Client Services on fact-gathering and PDMA investigations for incidents related to drug sample losses, thefts, concealed shortages, open AOCs, signature verification audits and sales rep activities.• Draft investigations summaries and compliance reports for client and agency submissions related to:o Theftso Significant Losses and Concealed Losseso Losses in Transito Negative AOCso Negative Signature Auditso Falsification of Recordso Non-compliance by Sales Representatives• Assist Regulatory Affairs and Compliance management on incident analysis and trending.• Conduct internal audits.• Handle any updates to company’s mid-level prescriptive authority table for Rx and DEA sampling (review FDA, DEA, HHS websites, state websites, and SHALL Regulatory Database).• Handle any updates to company’s State Loss / Theft Reporting

• Assist Compliance Manager/Sr. Manager in monitoring changes to PDMA requirements and state requirements for drug sampling and sales representative activities.• Monitor the state websites and regulatory database (i.e. SHALL) for legislative and regulatory updates.• Conduct regulatory research and preliminary analysis on federal and state investigation and reporting requirements.• Conduct regulatory research on mid-level prescriptive authority.• Assist with preparation of materials for client audits and production of records to satisfy auditor or client document requests.• Participate and contribute to projects having regulatory/compliance impact (e.g., review of programs business rules and related forms).• Assist with preparation of training materials that may include collaborating with Client Services or Compliance teams.• Maintain client-related Regulatory Affairs and Compliance files and archival.• Maintain Resource hours accurately to capture billable, non-billable and overtime hours.• Support Annual Regulatory training Program led by Sr. Compliance Manager for employees.

The above duties are meant to be representative of the position and not all-inclusive

Qualifications

MINIMUM JOB REQUIREMENTS:

• High School Diploma or equivalent• Four (4) years legal or compliance administrative background or legal/compliance support work experience

KNOWLEDGE, SKILLS & ABILITIES:• Excellent verbal and written communication skills• Excellent organization skills and detail oriented• Excellent interpersonal skills• Excellent organizational, prioritizing and follow-up skills• Excellent customer service awareness• Strong computer skills including Microsoft Word, Excel, and Outlook• Ability to balance multiple priorities to meet expected response deadlines• Ability to perform data entry• Demonstrated ability to learn new things quickly and proficiently• Basic understanding of data processing

PHYSICAL DEMANDS:• Location of job activities 100% inside• Noise and / or vibrations exposure• Reach, handle, and feel

• Stand and sit for prolonged periods of time• Lift, carry, and move up to 25 pounds

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an Equal Opportunity Employer