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Document Specialist – Consultant
Quanticate. Compile, format, and publish Clinical Study Reports (CSRs) and associated appendices in line with ICH E3 guidance and sponsor requirements.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in compiling and publishing Clinical Study Reports (CSRs) and regulatory documents while ensuring compliance with ICH E3 guidance and sponsor requirements. Proficient in document quality control, redaction processes, and maintaining publishing standards within a fast-paced pharmaceutical or biotechnology environment.
Highest-signal resume keywords
Clinical Study Report CompilationDocument Quality Control ReviewsAdobe Acrobat ProfessionalRegulatory Submission ProcessesAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study Report CompilationDocument Quality ControlRedaction of Clinical DocumentsDocument FormattingVersion ControlDocument Lifecycle ManagementCreating Bookmarks and HyperlinksRegulatory Document PublishingSOP ComplianceGCP Knowledge
Soft Skills
Excellent Written CommunicationStrong Interpersonal SkillsOrganisational SkillsAnalytical MindsetProblem-Solving Capabilities
Tools & Technologies
Adobe AcrobatMicrosoft WordDocument Management SystemsPublishing Software
Industry Keywords
Regulatory PublishingMedical Writing OperationsPharmaceutical IndustryBiotechnologyCRO Environment
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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