Regulatory Publishing Consultant
New
P
ProKidneyBiotech/Pharma
RemoteContractMiddle
Salary not disclosed
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Job Details
- Experience
- 3–5 years
- Required Skills
- SharePoint
Requirements
- 3–5 years of experience in Regulatory Publishing or Regulatory Operations within biotech, pharma, CRO, or consulting environments.
- Demonstrated hands-on experience producing submission-ready outputs, including advanced formatting and PDF QC.
- Proficiency in PerfectIt for editorial quality control.
- Proficiency in ISI Toolbox for regulatory publishing workflows.
- Experience with ESG (Electronic Submissions Gateway) or strong familiarity with the platform.
- Advanced proficiency in Adobe Acrobat Pro for PDF assembly and functional QC.
- Advanced Microsoft Word skills for document formatting.
- Experience with EndNote for reference management.
- Experience using SharePoint for document control and file management.
- Strong attention to detail and ability to manage multiple priorities under deadline.
- Ability to work independently in a remote environment.
Responsibilities
- Format and QC Word and PDF documents for submission readiness including layout, styles, and consistency checks.
- Apply advanced editorial tools like PerfectIt and ISI Toolbox to ensure compliance and accuracy.
- Create and QC PDFs using Adobe Acrobat Pro, including bookmarking, hyperlinking, and file assembly.
- Support submission package readiness and coordinate dispatch activities via Electronic Submissions Gateway (ESG).
- Manage reference materials using EndNote and maintain project files within SharePoint.
- Coordinate with Regulatory Affairs, Medical Writing, and Quality teams to clarify requirements and communicate risks.
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