Documentation Specialist in New Jersey

Document Specialist

We are seeking a detail-oriented and organized Document Specialist to join our team. The successful candidate will assist project teams with the preparation of regulatory documents and provide project management support. As a project team member, you will support prescribed activities for client and internal projects, adhering to strict timelines and quality standards.

Key Responsibilities:

Document Management:

• Prepare and review regulatory documents, including protocols, clinical study reports, and regulatory submissions.
• Prepare content plans, organize and categorize documents, ensuring accessibility and version control.
• Incorporate draft edits with extreme attention to detail, create and finalize abbreviation tables, and manage literature references and citations.
• Support e-publishing activities (formatting, creating eCTD...