Position Summary

ProKidney is seeking a Regulatory Publishing Consultant to support the preparation, QC, and publishing of submission-ready regulatory documents and dossiers. This consultant will work cross-functionally with Regulatory Affairs, Medical Writing, and Quality stakeholders to ensure documents are compiled accurately, formatted to required standards, and delivered on time for submissions and internal archiving.

This role requires strong technical document skills, excellent attention to detail, and hands-on proficiency with the required toolset: PerfectIt, ISI Toolbox, ESG (Electronic Submissions Gateway), Adobe Acrobat Pro, Microsoft Word, EndNote, and SharePoint.

Key Responsibilities (Deliverables-Focused)

• Prepare submission-ready documents and components
• Format and QC Word and PDF documents for submission readiness, including layout, styles, headers/footers, pagination, cross-references, and consistency checks.
• Apply advanced editorial/quality tools (PerfectIt, ISI Toolbox) to improve accuracy, consistency, and compliance with agreed templates/standards.
• PDF assembly and publishing support
• Create and QC PDFs using Adobe Acrobat Pro, including:
• Bookmarking and hyperlinking
• Document assembly/combination and file optimization
• Navigation and functional QC (links/bookmarks/tables/TOCs)
• File naming, version control, and readiness checks
• Submission support / dispatch coordination (as applicable)
• Support submission package readiness and provide required artifacts (e.g., package inventories, QC checklists).
• Support dispatch activities through ESG as scoped (or coordinate with internal staff managing ESG), ensuring confirmation evidence is captured and retained.
• Reference and document management
• Support reference management activities in EndNote (as needed for documents requiring citations/bibliographies).
• Maintain working files and deliverables within SharePoint, following folder structures, naming conventions, and document control expectations.
• Cross-functional coordination
• Coordinate efficiently with Regulatory Affairs, Medical Writing, and Quality contacts to obtain inputs, clarify requirements, and deliver completed outputs aligned to agreed timelines.
• Communicate risks early (e.g., missing source content, formatting issues, late changes impacting timelines).

Required Qualifications

• 3–5 years of experience in Regulatory Publishing / Regulatory Operations within biotech/pharma, CRO, or consulting environment.
• Demonstrated hands-on experience producing submission-ready outputs, including advanced formatting and PDF QC.
• Proficiency with:
• PerfectIt
• ISI Toolbox
• ESG (Electronic Submissions Gateway) (hands-on or strong familiarity, as scoped)
• Adobe Acrobat Pro
• Microsoft Word (advanced)
• EndNote
• SharePoint
• Strong attention to detail, document-quality mindset, and ability to manage multiple priorities under deadline.
• Ability to work independently in a remote environment with clear, proactive communication.

Preferred Qualifications

• Experience supporting eCTD and/or non-eCTD publishing workflows (region-specific experience a plus).
• Familiarity with common regulatory document standards and expectations (e.g., ICH structure awareness).
• Experience working with cross-functional submission teams and tight submission timelines.

Deliverables / Success Measures (Examples)

• On-time delivery of agreed publishing/formatting deliverables.
• High first-pass quality (minimal rework due to formatting/QC issues).
• Clear traceability and organization of working files in SharePoint.
• Effective communication of status, risks, and completion evidence (e.g., QC checklist, dispatch confirmation where applicable).

Engagement Logistics

• Location: Remote
• Working model: Deliverables-based; timelines and turnaround expectations agreed per project or submission plan. Hours will vary 20-40hrs/week