Document Management Specialist - Evergreen

Job Summary

The Document Management Specialist is responsible for processing study documentation in accordance with Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines and study specific TMF plans.

Essential Functions

• Support Trial Master File (TMF) set-up, maintenance, update, archival and closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations.
• Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving.
• Conduct detailed and appropriate quality checks (QC) on TMF documents at defined time points, including any paper originals required.
• Ensure that privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with retention practices.
• Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines.

Necessary Skills and Abilities

• Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.

Educational Requirements

• Bachelor's degree is preferred, however, candidates without a formal degree but who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.

Experience Requirements

• 0-3 years of experience in Document Control, Quality Assurance or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environment for Document Management Specialist role.
• Experience working in Electronic Document Management Systems; Veeva Vault experience is a plus.
• Exhibits a good understanding of general quality assurance concepts and practices.
• Highly organized with a strong attention to detail.
• Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.).