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Job Openings

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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