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.
- Cond

📌 Document Specialist (India)
🏢 Quanticate
📍 India