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Job Title

Compliance Analyst

Company : Knipper

Location : Lakewood, NJ

Created : 2020-09-12

Job Type : Full Time

Job Description

POSITION SUMMARY: The Compliance 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. J. Knipper and Company is an Equal Opportunity Employer POSITION 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. • Guide and direct the work of Mitigation team in the management of manual adjudication/prescriber validation services, as needed. • Collaborate with Professional Services and Sample Accountability 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 investigational summaries and compliance reports for client and agency submissions related to: o Thefts o Significant Losses and Concealed Losses o Losses in Transit o Negative AOCs o Negative Signature Audits o Falsification of Records o 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/Director in monitoring changes to PDMA requirements and state requirements for drug sampling and sales representative activities. • Monitor the Sharing Alliance website 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 Sample Accountability, Professional 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 Compliance Manager for employees. REQUIRED EDUCATION AND EXPERIENCE: • High School Diploma or equivalent • Four (4) years legal or compliance administrative background or legal/compliance support work experience PREFERRED EDUCATION AND EXPERIENCE: • Bachelor’s Degree or an equivalent amount of relevant experience • Experience within the pharmaceutical industry and/or pharmaceutical distribution and warehousing • Experience with cGMP, PDMA, DEA, HIPAA, and Part 11 regulatory requirements KNOWLEDGE, SKILLS & ABILITIES: • Excellent verbal and written communication skills • Excellent organization skills and detail oriented • Excellent interpersonal skills • Excellent organizational, prioritization 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 Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ID: 2020-1895 External Company Name: J. Knipper and Company, Inc. External Company URL: Street: 1 Healthcare Way