The Document Management Associate (DMA) (Levels 1 and 2) is responsible for the receipt and accurate logging of all incoming study documentation, scanning documentation to the correct location in an electronic repository; setting up the Trial Master File (TMF) per the approved specifications; maintenance and accuracy of the files; delivery of the Trial Master File at study closeout; and the resolution of any internal quality control findings or external compliance audit findings.
Level 3 Document Management Associates perform quality control reviews and tasks associated with non-standard client expectations , which include, but are not limited to, reconciliation of study documents, shipment of documents per client standards, and comparison of the electronic document repository to the paper TMF to ensure compliance of Document Management activities with regulatory requirements, PRA standard operating procedures, and client specifications.
Level 4 Document Management Associates provide supervisory oversight and training while contributing to key Document Management deliverables by organizing and executing tasks with the project team, management, and Document Management employees.Provides publishing support and expertise in the development of regulatory submissions.
• Develops strong knowledge of publishing systems, processes, and computer software (MS Word, Adobe Acrobat, ISI Toolbox).
• Exhibits ability to identify potential efficiencies and process improvements.
• Understands current regulatory guidance information, particularly related to publishing electronic submissions.
• Displays strong written and oral communication skills.
2 years of experience in a drug or biologic-related office environment
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.