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Freelancer

North Chicago, Illinois

Post Date: 12/18/2017 Job ID: 1781 Job Category: Clinical: Quality

Job Responsibilities:
  • Review/preparation of documents redacted for Commercially Confidential Information (CCI) and protected personal data (PPD) for public disclosure to meet various business needs. For example:
    • proposed and final redaction document packages for submission to the EMA in alignment with EMA Policy 0070 guidance or
    • the review of study protocols or SAPs for submission to journals in support of the primary endpoint manuscript publications,
  • Provides QC of above documents (for documents the service provider didn’ t prepare)
  • Assist with identifying CCI. This includes searching global external databases and other public sources of clinical and scientific information to confirm the information has not been publically disclosed.
  • Assist in creation of a repository of EMA Policy 43 requests, associated documents and correspondence.
  • Support global registration and results disclosure activities for compounds across pharmaceutical development and therapeutic areas.
  • Participate in any necessary meetings via teleconference
  • Incorporate feedback when provided
  • Meet timelines

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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