Document Specialist (Consultant)

About the role

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.

What you'll do

• Ensure that documents meet the highest standards of quality, consistency, and regulatory compliance
• Prepare submission-ready PDF documents with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents
• Ensure consistency in formatting, styles, numbering, references, and document structure across all deliverables
• Ensure compliance with sponsor templates, SOPs, and regulatory requirements
• Partner with authors and reviewers to resolve publishing, formatting, and quality issues

What you need

• 3–6 yrs of experience
• Stakeholder management
• CRO
• GCP
• Problem solving
• Process improvement
• Regulatory affairs
• B.Sc

Good to have

• SOP writing
• Clinical data management
• Pharmacovigilance