Publishers (US Submissions) Remote
25212 W IL Route 120 Round Lk Bch, IL 60073 US
- 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
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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