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Documentation Specialist

Duluth, GA 30096

Posted: 09/15/2023 Employment Type: Contract Job Category: Administrative Job Number: 579759 Country: United States Is job remote?: No

Job Description

Documentation Specialist
3-month contract
Location: Duluth, GA


Must Haves:
  • HS Diploma
  • MS Office (proficient)
  • Adobe Acrobat (proficient)
  • Ability to comply with all company procedures and processes, especially in regard to compliance
  • Pharmaceutical industry experience

Job Summary:

Provide documentation, including but not limited to invoices, and time recording at the direction of Senior Associate Director, or designee.

Support the Regulatory Affairs team in Duluth to ensure materials in Regulatory Archive are processed correctly and in compliance with procedures.

  • Properly index all local material  according to appropriate standards.
  • Locate and Transfer contents of CDs to an electronic file located in BI Central folder (TBD)
  • Perform OCR (Optical Character Recognition) on scanned files and CD contents as needed.
  • If applicable after OCR, verify destroy the hard copy files or CDs.
  • If the above is completed, then scan and process files
  • Manage the Chain of Custody procedures to ensure the integrity of all study documentation.
  • Performs other duties as assigned.
  • Professional knowledge of MS Programs and Adobe Acrobat
  • Demonstrated ability to multi-task and juggle competing priorities in a passionate, positive and professional manner
  • Demonstrated ability to comply with all company procedures and processes, especially in regard to compliance
  • Outstanding flexibility, adaptability and sense of accountability 
  • Self-starter and works independently
  • HS diploma
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