Document Specialist – Consultant

🔥 18 minutes ago

🇮🇳 India – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

💼 Consultant

👻 Ghost score 10%

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Quanticate

WebsiteLinkedInAll Job Openings

201 - 500 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Quanticate is a leading global biometric Contract Research Organisation (CRO) specializing in clinical data analysis for the pharma and biotech industries. They provide a range of services focused on enhancing clinical trial efficiency and success, including biostatistics, clinical data management, medical writing, and pharmacovigilance. Quanticate leverages advanced methodologies, such as Bayesian approaches, to optimize trial execution and data standardization, ensuring compliance with regulatory standards. They offer scalable resources tailored to client needs and have expertise across various therapeutic areas and trial phases, from early Phase I to post-marketing Phase IV trials. Quanticate is known for its robust data automation, visualisation, and analytics capabilities, which support decision-making and regulatory submissions.

📋 Description

• 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