Document Specialist (Consultant)
New
Q
QuanticateClinical regulatory documentation
Workable locations: IndiaContractMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum 3 years of experience in Regulatory Publishing, Medical Writing Operations, Document Publishing, or Regulatory Operations within a pharmaceutical, biotechnology, or CRO environment.
- Required Skills
- GCP
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or a related discipline.
- 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.
- 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.
Responsibilities
- Compile, format, and publish Clinical Study Reports (CSRs) and appendices in line with ICH E3 guidance and sponsor requirements.
- Prepare submission-ready PDFs with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents.
- Assemble supporting documentation from multiple teams and external vendors.
- Perform document-level QC reviews covering formatting, pagination, links, cross-references, tables, figures, listings, and completeness.
- Redact clinical and regulatory documents for ClinicalTrials.gov, CTIS, EudraCT, and other disclosure activities.
- Review redacted documents and remove confidential commercial information and personal data according to applicable regulations and sponsor guidance.
- Support electronic submission packages, document lifecycle management, version control, and archiving.
- Maintain publishing standards, templates, and document management processes, and contribute to inspection and audit readiness.
- Collaborate with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.
- Share best practices, support process improvements, and stay current with regulatory guidelines.
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