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- BrilliantLeap!
Regulatory 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 submissionsKnowledge of Microsoft Office toolsKnowledge and experience with Adobe Acrobat PDF filesAbility to multitask and work with multiple departmentsProblem solving and decision making skillsFamiliar with FDA/ICH guidelines for electronic submissionsFamiliar 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 FDAGive full Quality Assurance checks on electronic submissions to the FDAManage and track document and submission lifecyclesTrain colleagues and new hires on eCTD and the processesLead the entire publishing aspect of eCTD submissionsCoordinate the receipt of submission documents from various sources Assist IT in testing and implementing eCTD related systemsAuthor and maintain SOPs and Work Instructions for electronic submissionsWant to know more? First send your resume to then call 973-744-8164.