Document Specialist I

Roles & Responsibilities
• Compile appendices to Clinical Study Reports (CSRs) in compliance with regulatory requirements
• Format clinical documents in MS Word as per SOP/client/regulatory guidelines
• Use publishing software to create electronic deliverables with navigability and hyperlinking features
• Insert tables, apply templates, and ensure document consistency and accuracy
• Coordinate production and distribution of draft and final documents to project teams and clients
• Ensure submission-ready documents aligned with global regulatory standards
• Perform quality control checks on draft and final documents before distribution
• Support document project management activities, timelines, and deliverable tracking
• Participate in study team meetings and communicate publishing requirements
• Maintain proper filing of project documentation and ensure compliance with SOPs
• Assist in training/mentoring new team members as required

Qualification
• Bachelor’s degree in Health Sciences / Life Sciences
OR
• Degree in Computer Science / Technology or equivalent qualification

Experience
• Experience in document processing/publishing within clinical research environment
• Exposure to clinical trial submission dossiers, CSRs, and regulatory documents preferred
• Proven ability to format 15–17 pages per hour including post-PDF processing

Skills
• Advanced MS Word and MS Office formatting skills
• Advanced Adobe Acrobat (PDF processing) skills
• Knowledge of publishing software and document management systems
• Understanding of global regulatory submission formats and guidelines
• Proficiency in grammar, punctuation, and medical terminology
• Strong attention to detail and quality focus
• Ability to manage multiple tasks in a matrix team environment
• Excellent written and verbal communication skills

About the Organization
Parexel is a global clinical research organization dedicated to improving the world’s health by supporting pharmaceutical and biotechnology companies across clinical development, regulatory consulting, and market access, delivering patient-focused and high-quality clinical solutions worldwide.