Document Specialist (Consultant)

Quanticate; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Quanticate seeks a Document Specialist (Consultant) to ensure high-quality formatting, publishing, QC, and disclosure redaction of clinical and regulatory documents for worldwide submissions. You will collaborate with Medical Writing, Regulatory Affairs, Clinical Operations, and external vendors to deliver compliant, submission-ready packages.

Key duties include publishing CSRs, performing QC checks, redacting confidential information, and supporting document lifecycle management across

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or related discipline.
• Experience in regulatory publishing, medical writing operations, or document publishing is preferred.
• Proficiency with Adobe Acrobat and document publishing software required.

Responsibilities

• Publish and format CSRs and appendices with bookmarks, hyperlinks, and navigation tools per ICH E3 guidelines.
• Perform comprehensive document-level QC including pagination, cross-references, and layout consistency.
• Redact confidential information and ensure compliance for regulatory disclosure and transparency.
• Support submission-ready electronic document packages and maintain version control and archival processes.

Skills

Attention to detail

Communication

Organisational skills

Project coordination

Education

Bachelor's degree

Tools

Adobe Acrobat

Word processing tools

Document management systems

Job description

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

Support the preparation of submission-ready electronic document packages. Assist with document lifecycle management, version control, and archival activities. Maintain publishing standards, templates, and document management processes. Contribute to inspection and audit readiness activities.

Collaboration & Continuous Improvement

Work closely with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams. Share knowledge, mentor colleagues, and promote best practices across projects. Support process improvement initiatives and contribute to operational excellence. Stay current with evolving regulatory guidelines and industry best practices.

Quanticate Snapshot

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers' needs. Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development. We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want - developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Education

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or a related discipline.

Experience

Minimum 3 years of experience in Regulatory Publishing, Medical Writing Operations, Document Publishing, or Regulatory Operations within a pharmaceutical, biotechnology, or CRO environment.

• Hands-on experience compiling and publishing Clinical Study Reports (CSRs) and appendices.
• Experience creating and maintaining bookmarks, hyperlinks, cross-references, and navigation features in large regulatory documents.
• Experience using Adobe Acrobat Professional and document publishing software.
• Experience conducting document quality control reviews.
• Experience redacting Protocols, SAPs, CSRs, and other clinical documents for regulatory disclosure and transparency requirements.

Technical Skills

• Advanced proficiency in Microsoft Word, Adobe Acrobat, and document formatting tools.
• Strong understanding of clinical and regulatory documentation standards.
• Knowledge of GCP, regulatory submission processes, and transparency requirements.
• Experience with document management systems, version control, and document lifecycle management.

Personal Skills

• Excellent written and verbal communication skills.
• Exceptional attention to detail and quality focus.
• Strong planning, organisational, and prioritisation skills.
• Ability to manage multiple deliverables and