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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.

KEY RESPONSIBILITIES:

• Manages the renewal and maintenance of Knipper’s federal and state distributor and pharmacy licenses for all Knipper warehouse and pharmacy locations including the preparation of supporting documents for new and renewal licenses for submission to state licensing agencies.
• Communicate with licensing bodies to address inquiries, resolve issues, and follow up on renewal status.
• Assists with re-accreditation of Knipper by the National Association of Boards of Pharmacy for all warehouse locations, which includes annual compliance evaluations for all facilities
• Maintains Regulatory Affairs and Compliance files
• 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
• 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
• Draft investigational summaries and compliance reports for client and agency submissions related to:
  • Thefts
  • Significant Losses and Concealed Losses
  • Losses in Transit
  • Negative AOCs
  • Negative Signature Audits
  • Falsification of Records
  • Non-compliance by Sales Representatives
• Assist Regulatory Affairs and Compliance management on incident analysis and
• Conduct internal
• Handle any updates to company’s State Loss / Theft
• 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
• Conduct regulatory research and preliminary analysis on federal and state investigation and reporting
• Conduct regulatory research on mid-level prescriptive
• 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
• Maintain Resource hours accurately to capture billable, non-billable and overtime
• Support Annual Regulatory Training Program led by Compliance for employees.

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

MINIMUM JOB REQUIREMENTS:

Education/Training:  Bachelor’s degree or minimum 5 to 7 years compliance, licensing and/or agency reporting work experience.  Skilled in the pharmaceutical industry and/or pharmaceutical distribution and warehousing is highly desirable.

KNOWLEDGE, SKILLS & ABILITIES:

• Knowledge of pharmaceutical industry, including drug storage and distribution
• Knowledge of inspection process for drug sample distribution
• Strong knowledge of Federal and State Licensing requirements, PDMA and DSCSA
• Experience working on regulatory submissions.
• Excellent communication skills, written and verbal, organizational and data entry skills.
• Computer skills: Proficient in MS Office, Excel, and Word; basic understanding of data processing, ability to learn new business and warehouse management software/systems
• Detail oriented and has computer knowledge and good customer service awareness

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.