Parexel, a global leader in biopharmaceutical services, is hiring a Document Specialist I for its Medical Writing Support team. This is a full-time remote opportunity in India, open to candidates based in Mumbai, Hyderabad, Bengaluru, Chandigarh, and other locations.
This role is ideal for professionals with experience in clinical document compilation, publishing, and regulatory submission formatting, who want to contribute to global clinical trials and regulatory deliverables that directly impact patient health.
At Parexel, every role supports the mission of improving the world’s health through high-quality clinical research and regulatory excellence.
Key Responsibilities – Document Specialist I
Compilation & Publishing
- Compile appendices for Clinical Study Reports (CSRs) in line with global regulatory requirements
- Coordinate with Medical Writers, Clinical Teams, and Project Leadership to ensure document completeness
- Apply MS Word formatting as per SOPs, client, and regulatory standards
- Create submission-ready electronic documents with accurate hyperlinks and navigability features
- Manage draft and final document distribution to internal teams and clients
Quality Control (QC)
- Perform quality checks to ensure documents are submission-ready
- Ensure compliance with ICH, regulatory guidelines, and client SOPs
- Review draft and final documents prepared by other Document Specialists under supervision
Document Project Management
- Act as the Document Specialist representative on assigned projects
- Support timeline planning, issue resolution, and document approval workflows
- Maintain proper filing of project documentation and client deliverables
Training & Compliance
- Complete all required corporate and project-specific training
- Support mentoring and onboarding of new team members
- Ensure compliance with departmental workload trackers and procedures
Required Skills
- Advanced proficiency in MS Word and MS Office formatting
- Strong expertise in Adobe Acrobat (PDF processing)
- Experience with publishing software and document management systems
- Ability to format and QC 15–17 pages per hour
- Knowledge of medical and pharmaceutical terminology
- Excellent communication, multitasking, and teamwork skills
- High attention to detail and ability to work in a matrix environment
Education & Experience
- Bachelor’s degree (or equivalent) in Life Sciences, Pharmacy, Health Sciences, or Computer Science/Technology
- Proven experience in clinical document publishing, submission dossiers, CSRs, or regulatory documents
- Experience as a Document Technologist / Document Specialist is preferred
Why Join Parexel?
- Work with a globally respected CRO
- Exposure to international clinical trials and regulatory submissions
- Fully or partially remote work opportunities in India
- Collaborative and patient-centric work culture
- Career growth in medical writing support and regulatory publishing
Job Locations
- Remote – India
- Mumbai (Remote)
- Hyderabad (Remote / Onsite)
- Bengaluru (Remote)
- Chandigarh (Remote)
Estimated Salary (India)
₹4,00,000 – ₹9,00,000 per annum
(Based on industry standards for Document Specialist roles in global CROs)
How to Apply
