Document Specialist – Consultant
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Job Description
Document Specialist compiling, quality-checking, and redacting clinical and regulatory documents for Quanticate, a global data-focused CRO. Supporting submissions, disclosure, document lifecycle management, and audit readiness.
Responsibilities:
- 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 clinical and regulatory documents for global submissions.
- Assemble appendices and supporting documentation from multiple teams and external vendors.
- Ensure consistency in formatting, styles, numbering, references, and document structure.
- Perform document-level quality control reviews covering formatting, pagination, hyperlinks, bookmarks, cross-references, tables, figures, listings, completeness, and quality.
- Ensure compliance with sponsor templates, SOPs, and regulatory requirements.
- Resolve publishing, formatting, and quality issues with authors and reviewers.
- Redact clinical and regulatory documents for ClinicalTrials.gov, CTIS, EudraCT, public disclosure, and transparency requirements.
- Redact confidential commercial information and personal data according to regulations and sponsor guidance.
- Conduct QC reviews of redacted documents before publication or submission.
- Support submission-ready electronic document packages, document lifecycle management, version control, and archival activities.
- Maintain publishing standards, templates, and document management processes.
- Contribute to inspection and audit readiness activities.
- Collaborate with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.
- Share knowledge, mentor colleagues, promote best practices, support process improvement, and contribute to operational excellence.
- Stay current with evolving regulatory guidelines and industry best practices.
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.
- 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 meet deadlines in a fast-paced environment.
- Analytical mindset with strong problem-solving capabilities.
- Self-motivated with the ability to work independently and collaboratively.
- Strong interpersonal and stakeholder management skills.
Benefits:
- Competitive salary
- Flexible working hours
- Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
- Medical Insurance for self and immediate family
- Gratuity
- Accidental Coverage
- Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)
- Membership to professional societies
- Career development opportunities
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