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Drug Safety Documentation Specialist

Edison-New Brunswick Metro Area, NJ

Posted: 02/07/2019 Job Type: Scientific Job Number: JN -022019-23625
Document Specialist supports formatting and workflows of documents as required to ensure documents are publishing and submission ready. Aggregate Safety Reporting

Responsibilities will 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 teams internal to GDSRM and teams external to GDSRM within Celgene
Communicating with external partners who might need our documents

Skills/Knowledge Required:

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
Strong communication skills (both oral and written) and the ability to interact with various levels, both within department as well as with other parts of the organization
Keen attention to detail
Knowledge of eCTD documentation requirements
Demonstrated ability to work independently with effective presentation and interpersonal skills to ensure a team-oriented approach
Ability to work as part of a team, multi-task and meet internal and regulatory deadlines
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