Regulatory Publisher

Employment Type

: Full-Time

Industry

: Miscellaneous



Role:                   Regulatory Publisher-eCTD
Emp Type:          Long Term Contract
Interview:           Phone/Skype
Location:            Remote

Minimum 4 years of eCTD publishing experience required
Experience in eCTD publishing for low/medium complexity in one or more ICH region
Experienced with IND and NDA eCTD submissions.
Submission publishing includes creating navigation in PDF document Clinical study report, CRF processing, word formatting and publishing of eCTD, NeeS and Paper
Experience with mainstream publishing tools (e.g. Insight publisher or DocuBridge or eCTDXpress)
Broad technical knowledge (MS Word, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel)
Experience in global eCTD filing 
Reviewing the publishing request and processing as per provided comments and regulatory requirements
Processing PDF document using publishing plug-ins (Smart desk/ISI tool box or any other tool)
Prepare submission planner as per submission type for US, EU and ROW market 
Preparing, compiling and publishing eCTD submission based on client requirements 
Performing external hyper linking task for the published output document and validation of the submission.

Must exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects.
Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Lync, Access, Documentum, Insight Publisher/DocuBridge/eCTDXpress, Insight Validator eCTD viewers and web-based applications) and be technically savvy with such systems.

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