Document Specialist – Consultant

This is a fully remote position, open to applicants in India.

📋 Description

• Compile, format, and disseminate Clinical Study Reports (CSRs) along with relevant appendices in accordance with ICH E3 guidelines and sponsor specifications.

• Create submission-ready PDF documents that include bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents.

• Assemble and publish clinical and regulatory documents for global submissions.

• Gather appendices and supporting materials from various teams and external vendors.

• Ensure uniformity in formatting, styles, numbering, references, and document structure.

• Conduct document-level quality control reviews that encompass formatting, pagination, hyperlinks, bookmarks, cross-references, tables, figures, listings, completeness, and overall quality.

• Maintain compliance with sponsor templates, standard operating procedures (SOPs), and regulatory requirements.

• Address publishing, formatting, and quality concerns with authors and reviewers.

• Redact clinical and regulatory documents in line with ClinicalTrials.gov, CTIS, EudraCT, public disclosure, and transparency mandates.

• Safeguard confidential commercial information and personal data following regulations and sponsor guidelines.

• Perform quality control reviews of redacted documents prior to publication or submission.

• Assist in preparing submission-ready electronic document packages, managing document lifecycles, version control, and archival processes.

• Uphold publishing standards, templates, and document management protocols.

• Participate in activities to ensure readiness for inspections and audits.

• Collaborate with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.

• Share expertise, mentor colleagues, advocate for best practices, support process enhancements, and contribute to operational excellence.

• Stay informed of evolving regulatory guidelines and industry best practices.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or a related field.

• At least 3 years of experience in Regulatory Publishing, Medical Writing Operations, Document Publishing, or Regulatory Operations within a pharmaceutical, biotechnology, or CRO context.

• Practical experience in compiling and publishing Clinical Study Reports (CSRs) and appendices.

• Proficiency in creating and maintaining bookmarks, hyperlinks, cross-references, and navigation features in extensive regulatory documents.

• Familiarity with Adobe Acrobat Professional and document publishing software.

• Experience in conducting document quality control reviews.

• Background in redacting Protocols, SAPs, CSRs, and other clinical documents to meet regulatory disclosure and transparency requirements.

• Advanced skills in Microsoft Word, Adobe Acrobat, and document formatting tools.

• Strong comprehension of clinical and regulatory documentation standards.

• Knowledge of Good Clinical Practice (GCP), regulatory submission processes, and transparency expectations.

• Experience with document management systems, version control, and document lifecycle management.

• Excellent written and verbal communication capabilities.

• Meticulous attention to detail and a strong focus on quality.

• Strong organizational, planning, and prioritization abilities.

• Capability to handle multiple deliverables and adhere to deadlines in a fast-paced environment.

• Analytical mindset with robust problem-solving skills.

• Self-driven with the capacity to work both independently and in collaboration with others.

• Strong interpersonal and stakeholder management abilities.

🏝️ 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 provides various learning and development opportunities to promote your growth (mentoring, coaching, e-learning, job shadowing)

• Membership in professional societies

• Opportunities for career development