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Regulatory Affairs Associate
Ref No.: 17-51751
Location: Cambridge, Massachusetts
Start Date / End Date: 05/29/2017 to 12/01/2017
Job Summary
Company:                Artech Information Systems LLC
Posting Title:            Document Management Specialist

Job Id:                      BIIBJP00008842
Location:                 Cambridge, MA
Duration:                 6+ months
Job Description: 
The primary purpose of this job is to file, review, and remediate documents required for the Medical Writing and Clinical Trial Application (CTA) sections of client’s Trial Master Files (TMF). 
Job responsibilities include: 
• Performs quality control on documents to be submitted to the TMF 
• Identifies missing documentation and follows-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation. 
• Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfilled documentation; performing periodic review and remediation of TMF. 
• May participate in Inspection Readiness activities as needed 
• May perform document approval and notification processes 
Qualifications: 
• Knowledge of and direct experience with Trial Master File required 
• Exceptional attention to detail required 
• Ability to multitask in a fast-paced environment 
• Highly organized 
• Ability to prioritize while adhering to project deadlines 
• Good understanding of the biotechnology/pharmaceutical industry and the clinical development process, preferred 
• Familiarity with Regulatory Clinical Trial Applications, preferred 
Education: 
• Bachelor’s degree or equivalent