Document Specialist I
📄 About Parexel
Parexel is a globally recognized Clinical Research Organization (CRO) delivering biopharmaceutical services that accelerate drug development and regulatory success.
With operations across multiple countries, Parexel supports global clinical trials, regulatory submissions, and medical writing excellence that directly impact patient health.
📌 Job Overview – Document Specialist I
Parexel is hiring a Document Specialist I within its Medical Writing Support team.
This full-time role focuses on clinical document compilation, publishing, formatting, quality control, and regulatory submission readiness for global clinical trials.
Open to candidates across Mumbai, Hyderabad, Bengaluru, Chandigarh, and remote locations in India.
🧾 Key Responsibilities
- Compile Clinical Study Report (CSR) appendices per global regulatory standards
- Format documents using advanced MS Word templates
- Create submission-ready electronic documents with hyperlinks
- Perform QC checks for compliance with ICH & regulatory guidelines
- Coordinate with Medical Writers and Clinical Teams
- Manage document distribution and version control
- Support project timelines and approval workflows
- Maintain project documentation and client deliverables
- Mentor new team members when required
🧠Required Skills
- Advanced MS Word & MS Office formatting expertise
- Strong Adobe Acrobat PDF processing skills
- Experience with publishing tools & document management systems
- Ability to format 15–17 pages per hour
- Knowledge of medical & pharmaceutical terminology
- Excellent communication & multitasking skills
- High attention to detail in regulatory environments
🎓 Eligibility & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences, or Technology
- Minimum 3 years experience in document publishing / regulatory submission roles
- Experience as Document Technologist or Document Specialist preferred
- Experience in CSR compilation & submission dossiers highly desirable
💼 Why Join Parexel?
- Work with a globally respected CRO
- Exposure to international regulatory submissions
- Remote / hybrid flexibility in India
- Career growth in Medical Writing & Regulatory Publishing
- Collaborative and patient-centric culture
💰 Estimated Salary (India)
- ₹4,00,000 – ₹9,00,000 per annum
- Final compensation based on experience & internal benchmarks
We use a 15-second timer to encourage candidates to read the job description carefully before applying. Ensure your experience matches regulatory publishing and clinical documentation requirements.
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