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Publishers (US Submissions) Remote

Round Lk Bch, IL 60073

Posted: 09/20/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 586208 Is job remote?: Yes Country: United States

Job Description

Job Desc:
  • This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements
  • Serves system administrator for the client's US Regulatory electronic document management system
  • He/she will serve as the primary publisher of US Regulatory submissions (Drug and Device)
  • Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time
  • Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements
  • Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types
  • Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System

Skills Required:

We are looking for someone with submission experience with FDA, someone who can support Drug/Device submissions using eCTDXpress and document management tools (like RIM).

100% Remote is Allowed* CO and NYC candidates may not be considered 
Target pay: 29-31/hr
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