Regulatory Submissions Publisher-eCTD-ISI

Under the title Medical Writer 1
Submission Publisher:7514
32-38.00 an hour w2 contract 05/25/2015 to 12/31/2015
Job Description:
Publish regulatory-compliant submissions in paper, NeeS or eCTD format using regulatory publishing software tools.
Perform detailed quality reviews of published submissions to ensure compliance with CLIENT'S standards and agency guidances. This includes verification of bookmarks, hypertext links and tables of content in electronic submissions.
Perform post-publishing phases of regulatory submission production including submission dispatch to regulatory agencies or Area & Affiliate staff and submission archiving, where applicable.
Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines.
Represent Submission Publishing on submission teams as necessary elevating timeline issues to Submission Management or Functional Manager.
Prepare IND safety cover letters and IND amendment submissions to FDA.
Track metrics associated with submission publishing.
2-3 years eCTD submission experience and/or publishing experience.
Experienced in the use of publishing-related software tools including Documentum, eCTDXPress, ISI Toolbox, Adobe Acrobat.
Thorough understanding of MS Word.
Experience in working with multiple systems.
Bachelor's degree preferred.

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