Job Title: Document Specialist I
Location: India (Remote) | Hyderabad, India
Employment Type: Full-Time
Company: Parexel
Parexel is seeking a highly detail-oriented Document Specialist I to support global medical writing and clinical research activities. This role is critical in the compilation, formatting, publishing, and quality control of clinical and regulatory documents submitted to global health authorities. The ideal candidate will have strong document publishing expertise, a solid understanding of regulatory standards, and the ability to work collaboratively in a matrix environment.
This position offers the opportunity to work on diverse clinical research documents while growing within a globally recognized clinical research organization that values learning, inclusivity, and professional development.
Compile appendices for Clinical Study Reports (CSRs) in compliance with global regulatory requirements, SOPs, and client guidelines
Support project leads and lead medical writers to ensure documentation completeness and submission readiness
Apply advanced MS Word formatting to clinical documents, including tables, figures, and templates
Use publishing and document management software to create electronic deliverables with accurate hyperlinking and navigability features
Coordinate production, tracking, and distribution of draft and final documents to internal teams and clients
Provide technical and document-related support to Medical Writing Services (MWS) staff
Perform thorough quality checks to ensure accuracy, consistency, and regulatory compliance
Review draft and final documents prepared by other Document Specialists under appropriate supervision
Ensure documents meet global regulatory submission standards and internal/client style guidelines
Act as the primary contact for assigned compilation and publishing projects under departmental supervision
Support timeline negotiations, issue resolution, and document approval workflows
Participate in study team meetings and communicate document requirements, timelines, and expectations
Manage collection and proper filing of project documentation and client deliverables
Complete all mandatory corporate, departmental, and project-specific training
Support training and mentoring of new team members when required
Participate in departmental and company meetings
Maintain workload trackers and project assignment records
Provide administrative and operational support as needed
Excellent written, verbal, and interpersonal communication skills
Strong attention to detail with the ability to manage multiple tasks and deadlines
Client-focused mindset with a flexible and proactive approach
Ability to work effectively in cross-functional and matrix teams
Advanced proficiency in MS Word and MS Office, including templates, styles, tables, and quality checks
Advanced skills in Adobe Acrobat and PDF processing
Experience with document management systems and publishing software
Strong understanding of grammar, punctuation, and medical/pharmaceutical terminology
High typing speed and advanced keyboard skills
1–3 years of relevant experience in document processing, publishing, or clinical documentation
Proven experience handling multiple clinical documents such as clinical study reports, submission dossiers, and regulatory documents
Demonstrated productivity in document formatting and post-PDF work (approximately 15–17 pages per hour)
Bachelor’s degree or regionally accepted equivalent in Health Sciences, Life Sciences, Pharmacy, Computer Science, Information Technology, or a related field
Candidates with significant hands-on experience in clinical document processing or publishing will be preferred
Work on global clinical research projects with real-world patient impact
Structured career development with mentoring, job rotation, and learning opportunities
Inclusive, collaborative, and growth-oriented work culture
Performance-based career progression aligned with global standards
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