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