Location: India (Remote / Hyderabad)
Job Category: Medical Communication / Scientific Writing / Clinical Documentation
Employment Type: Full-Time, Permanent
About the Role
Parexel is seeking a Document Specialist I to join our global Medical Writing team. This role focuses on the compilation, publishing, and quality control of clinical research documents that support regulatory submissions and clinical trials. The ideal candidate will combine strong scientific knowledge, advanced document management skills, and attention to detail to ensure high-quality, submission-ready documents.
As part of a collaborative, cross-functional team, you will contribute to clinical study reports, informed consent forms, appendices, pharmacovigilance documents, and other scientific deliverables, ensuring compliance with global regulatory standards.
Key Responsibilities
Document Compilation & Publishing
Compile appendices and other supporting documents for clinical study reports in accordance with regulatory guidelines and project requirements.
Apply departmental publishing software to produce electronic deliverables with proper navigability, hyperlinking, and formatting.
Format clinical documents using MS Word and insert tables or figures as needed.
Coordinate distribution of draft and final documents to project teams and clients, ensuring timely delivery.
Quality Control & Compliance
Ensure all documents are submission-ready, compliant with regulatory guidelines, and adhere to departmental SOPs and style guides.
Conduct thorough quality checks of own work and provide reviews of documents prepared by other team members.
Maintain accurate records and project files for audits and inspections.
Project Coordination & Management
Act as a point of contact for document compilation and publishing projects under departmental supervision.
Support negotiation of deliverable timelines and resolve project-related issues in collaboration with the project lead.
Track project progress, maintain schedules, and proactively communicate status updates to stakeholders.
Training & Mentorship
Assist in onboarding and mentoring junior team members in document management practices.
Participate in mandatory and project-specific training programs to ensure continuous professional development.
Skills & Competencies
Strong interpersonal, verbal, and written communication skills.
Excellent attention to detail, deadline-oriented, and capable of managing multiple tasks simultaneously.
Advanced proficiency in MS Word/Office, Adobe Acrobat, and other document publishing tools.
Familiarity with clinical and regulatory documentation standards.
Knowledge of medical and pharmaceutical terminology is preferred.
Ability to work independently as well as collaboratively in a matrixed, remote team environment.
Experience & Qualifications
Experience: 3–5 years in document management, medical writing, or clinical documentation in a pharmaceutical, biotechnology, or CRO environment.
Proven experience in formatting, compiling, and publishing complex clinical trial documents.
Education: Bachelor’s degree in Health Sciences, Life Sciences, Pharmacy, or a related field. Advanced qualifications or significant hands-on experience in document publishing is a plus.
Why Parexel?
Work remotely or from our Hyderabad office, collaborating with global medical writing teams.
Gain exposure to diverse therapeutic areas and complex clinical projects.
Opportunities for career growth, mentorship, and professional development.
Contribute to patient-focused clinical research that improves healthcare outcomes worldwide.
Apply today to join one of the world’s leading medical writing teams and advance your career in clinical documentation and scientific communication.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Ciudad de México | New Mexico |Dubai :
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Jeddah | Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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