[Hiring] Document Specialist @Quanticate

Role 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.

Qualifications

• 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.

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 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)