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Documentation Specialist - Regulatory

Edison-New Brunswick Metro Area, NJ

Posted: 05/30/2019 Job Type: Scientific Job Number: JN -052019-24974
Document Specialist supports formatting and workflows of Global Drug Safety Reporting documents as required to ensure documents are publishing and submission ready.

Responsibilities include, but are not limited to, the following:
Formatting Microsoft Word documents and templates
Formatting Portable Document Format (PDF) documents using TRS Toolbox
Initiating workflows in the document management system
Communicating with external partners who might need our documents

Education: BA, BS, or combination of degree and appropriate work experience
Experience: Two to three years relevant experience in pharma/biotech, preferably in Regulatory Operations or another group supporting document formatting
Excellent Microsoft Office products skills: Word, Outlook, Excel, PowerPoint required; Visio and Livelink (or similar document management platform) desirable
Previous experience with and knowledge of TRS Toolbox required
Experience with StartingPoint Templates or equivalent
Experience with document management systems and/or electronic shared work spaces, e.g., SharePoint
Knowledge of eCTD documentation requirements
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