Document Specialist I – Clinical Document Publishing
Company: Parexel
Locations: Mumbai, Hyderabad, Chandigarh, Bengaluru | India | Remote / Hybrid | Full-Time | Job ID: R0000037893
Build a Career with Purpose in Clinical Research
Join a global clinical research organization dedicated to improving global health outcomes through clinical development, regulatory services, and market access solutions. At Parexel, every role contributes to the development of therapies that positively impact patients worldwide. The organization fosters a culture of collaboration, empathy, and scientific excellence.
Job Overview
The Document Specialist I supports clinical document compilation and publishing activities for regulatory and clinical study submissions. The role involves formatting, reviewing, and managing clinical documentation in compliance with global regulatory requirements and industry standards.
This position collaborates with clinical teams, project leadership, and medical writing support teams to ensure submission-ready documents, maintain quality standards, and manage document workflows across clinical development projects.
Key Responsibilities
Clinical Document Compilation and Publishing
Compile appendices for clinical study reports in compliance with regulatory requirements under guidance from project leads and medical writers.
Ensure completeness and regulatory compliance of appendix documentation through collaboration with clinical and project leadership teams.
Apply knowledge of global regulatory submission formats, industry standards, and publishing best practices.
Produce electronic deliverables using departmental publishing software, ensuring document navigability and accurate hyperlinking.
Format clinical documents using Microsoft Word according to standard operating procedures, client specifications, and regulatory requirements.
Insert tables and manage document layouts as required.
Coordinate production and distribution of draft and final documents to project teams and clients.
Track and manage document deliverables to ensure timely completion.
Provide technical support related to publishing software and document processing.
Quality Control and Compliance
Conduct quality checks to ensure all documents meet regulatory submission standards before internal or external distribution.
Ensure compliance with corporate, departmental, and client standard operating procedures and style guidelines.
Review draft and final documents prepared by other document specialists under supervision.
Document Project Management
Support document compilation and publishing projects, including timeline coordination and issue resolution.
Act as a document specialist representative on assigned projects under departmental supervision.
Communicate document requirements, coordinate reviews, and participate in study team meetings.
Manage document approval workflows and distribute final deliverables as per project agreements.
Collect and organize documentation for project files and client deliverables.
Support project documentation filing in collaboration with medical writing support teams.
Training and Operational Support
Complete mandatory corporate and project-specific training programs.
Support training and mentoring activities for new team members.
Attend departmental meetings and maintain project workload tracking systems.
Provide administrative support when required.
Required Skills
Strong verbal and written communication skills with a proactive approach to work.
Client-focused mindset with strong attention to detail.
Ability to manage multiple tasks and prioritize work effectively in a matrix environment.
Advanced proficiency in Microsoft Word and Office tools, including formatting templates, editing tables, and performing quality checks.
Advanced skills in Adobe Acrobat for PDF processing.
Experience with document editing tools, template design, and publishing software.
Knowledge of document management systems and clinical publishing workflows.
Proficiency in grammar, spelling, and medical or pharmaceutical terminology.
Strong organizational and teamwork skills.
Required Experience
Demonstrated experience in document processing or publishing using word processing and clinical publishing software.
Proven ability to format and process clinical documents efficiently, including clinical study reports and regulatory submission dossiers.
Experience working independently on document publishing tasks with measurable productivity standards (e.g., formatting 15–17 pages per hour).
Experience handling clinical documents of varying complexity in pharmaceutical, clinical research, or healthcare environments.
Educational Qualifications
Bachelor’s degree or equivalent qualification in health-related sciences with relevant document processing or publishing experience; or
Degree in computer science, information technology, or related discipline with relevant clinical documentation experience.
About the Organization
Parexel is a global clinical research organization providing comprehensive clinical development, regulatory consulting, and market access services. The organization partners with pharmaceutical and biotechnology companies to accelerate drug development and deliver life-changing therapies to patients worldwide.
Apply Now
Advance your career in clinical research documentation and regulatory publishing by joining a global team committed to scientific quality, regulatory excellence, and improved patient outcomes.
exp level
For the Document Specialist I role at Parexel, the experience level is:
Experience Level: Entry-Level to Early Career (0–3 years preferred)
Explanation:
The role requires demonstrated experience in document processing or clinical publishing but does not specify extensive industry experience.
It operates under supervision and includes training, mentoring support, and guided project responsibilities.
Typically suitable for fresh graduates with relevant skills or professionals with up to 3 years of experience in clinical documentation, publishing, or regulatory document processing.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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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 :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Prague |Chile :
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Sofia |Sweden :
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