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Senior eCTD Publisher - (US-NJ-Lawrenceville)
Compensation: $55K - $90K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: JV 061409
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Click Here to Apply OnlineRegulatory Publishers, Step On Up
BrilliantLeap!, the source for Regulatory Submissions experts worldwide, is currently conducting a search for a Lead Publisher experienced with both eCTD and paper dossier publishing.
In this role, you’ll be a big fish in a mid-sized pond, which means that you’ll be highly visible and have the opportunity to wear a lot of hats, to be seen strutting your stuff, and to be recognized and promoted (or not) because of your work.
Minimum Requirements:
Experience with Document Management Systems (Documentum)
Experienced with software applications for generating eCTD submissions
Knowledge of Microsoft Office tools
Knowledge and experience with Adobe Acrobat PDF files
Ability to multitask and work with multiple departments
Problem solving and decision making skills
Familiar with FDA/ICH guidelines for electronic submissions
Familiar with and experienced with eCTDs format
Responsibilities:
Utilize software applications to create eCTD dossiers (ISI’s eCTDXPress)
Create bookmarks and hyperlinks in PDF files for submission to the FDA
Give full Quality Assurance checks on electronic submissions to the FDA
Manage and track document and submission lifecycles
Train colleagues and new hires on eCTD and the processes
Lead the entire publishing aspect of eCTD submissions
Coordinate the receipt of submission documents from various sources
Assist IT in testing and implementing eCTD related systems
Author and maintain SOPs and Work Instructions for electronic submissions
Want to know more? First send your resume to Virginia@BrilliantLeap.com then call 973-744-8164.
Virginia Backaitis
BrilliantLeap!
41 Vreeland Ave
Totowa, NJ 07512
Phone: 973-744-8164
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