PAI Readiness Consultant (LS-220470)
Start Date: May 2017
Location: West Coast
Duration: End of 2017
Pay Rate: DOE
Type: Contract
Job Description The client is preparing to be inspection ready by January 2018 for an FDA PAI audit and will need a consultant to work on preparing the company and their CMOs, suppliers, etc. for the PAI.  

The consultant will be working for representatives from various departments including:
  • Regulatory
  • Late Stage Clinical Operations
  • Clinical Development
  • Data Management,
  • Biostatistics/Biometrics
  • Process Development
  • Analytical Development
  • Quality Operations
  • Clinical quality
  • CMOs and CROs that are sourced in phase III
  • Late Stage Clinical Material
  • Manufacturing

The client has a list of the documents that each team is responsible for, but the departments and will be required to become experts in the documents content, perform risk management related to their areas and understand what questions may be asked and how to become better prepared for the PAI.  In addition, the consultant will be responsible for developing a “story board” for the company, develop metrics/map of which documents are kept in house, who owns what documents, perform the risk assessment, and develop risk management related metrics and other logistical items associated with the PAI preparation. 

Required Skills:
  • Experience assisting with multiple PAI readiness audits
  • Small to mid-sized biotech and/or pharma company experience
  • Strong project management and leadership skills
  • Ex-FDA experience preferred
  • Clinical, CMC, and GMP
  • Pharmacovigilance experience
  • Drug safety exposure experience

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