Document Specialist (Consultant)

Are you passionate about delivering high-quality clinical and regulatory documents that support global submissions and clinical trial transparency? We are looking for a Document Specialist (Consultant) to join our team and play a key role in the formatting, publishing, quality control, and disclosure-related redaction of clinical and regulatory documentation. Working closely with Medical Writing, Regulatory Affairs, Clinical Operations, and other cross-functional teams, you will ensure that documents meet the highest standards of quality, consistency, and regulatory compliance. Document Publishing & Compilation Compile, format, and publish Clinical Study Reports (CSRs) and associated appendices in line with ICH E3 guidance and sponsor requirements. Prepare submission-ready PDF documents with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents. Compile and publish a variety of clinical and regulatory documents for global submissions. Assemble appendices and supporting documentation received from multiple teams and external vendors. Ensure consistency in formatting, styles, numbering, references, and document structure across all deliverables. Quality Control Perform comprehensive document-level QC reviews to ensure: Accurate formatting and pagination Functional hyperlinks and bookmarks Correct cross-references Consistent tables, figures, and listings Overall document completeness and quality Ensure compliance with sponsor templates, SOPs, and