Document Specialist

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 regulatory requirements.

• Partner with authors and reviewers to resolve publishing, formatting, and quality issues.

Disclosure & Redaction

• Perform redaction of clinical and regulatory documents to support:

• ClinicalTrials.gov submissions

• CTIS submissions

• EudraCT disclosure activities

• Public disclosure and transparency requirements

• Redact confidential commercial information (CCI) and personal data according to applicable regulations and sponsor guidance.

• Conduct QC reviews of redacted documents before publication or submission.

Regulatory Operations Support