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 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.
Requirements
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 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.
Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.
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)