Regulatory Publishing Consultant

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ProKidney Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🧬 Biotechnology

⚕️ Healthcare Insurance

Biotechnology • Healthcare Insurance

ProKidney Corp. is a late clinical-stage biotechnology company focused on pioneering cell therapy as a treatment for Chronic Kidney Disease (CKD). Their innovative approach aims to transform the therapeutic options available for advanced CKD by preserving kidney function, potentially delaying or eliminating the need for dialysis. With a focus on an area of high unmet medical need, ProKidney's cell therapy candidate, rilparencel, is at the forefront of clinical studies to provide alternative solutions for patients with limited treatment options. The company is committed to advancing its pipeline through clinical and regulatory developments and actively participates in healthcare conferences to bring attention to its groundbreaking work in CKD treatment.

📋 Description

• 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. • 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. • 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. • 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. • 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).

🎯 Requirements

• 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.

🏖️ Benefits

• ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. • Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.