Remote Jobs Parexel Hiring Document Specialist I for clinical document publishing and regulatory submission formatting professionals.
The clinical research and regulatory publishing domain continues to offer strong career opportunities for professionals skilled in document management and submission publishing. Parexel is currently inviting applications for the role of Document Specialist I, offering remote work flexibility across multiple Indian locations.
This position is ideal for candidates with experience in clinical document formatting, regulatory publishing, and submission-ready documentation who are looking to work in a globally recognized CRO environment. Parexel Hiring Document Specialist I
Company Overview
Parexel is a global Clinical Research Organization (CRO) providing comprehensive clinical development, regulatory consulting, and market access solutions to pharmaceutical and biotechnology companies. The organization supports sponsors throughout the entire drug development lifecycle, from early-phase trials to regulatory approvals.
With a strong global presence and a collaborative work culture, Parexel focuses on delivering high-quality clinical documentation and regulatory submission services aligned with international guidelines. Parexel Hiring Document Specialist I
Job Location & Employment Type
- Work Mode: Remote (India)
- Locations Covered: Mumbai, Hyderabad, Chandigarh, Bengaluru (Remote flexibility available)
- Employment Type: Full-Time
- Department: Medical Writing Support / Document Publishing
Open Position Details
Document Specialist I
This role involves compilation, formatting, publishing, and quality control of clinical documents in accordance with global regulatory standards. The selected candidate will work closely with medical writers, clinical teams, and project leadership to ensure submission-ready documentation.
Key Roles & Responsibilities
1. Document Compilation & Publishing
- Compile appendices for Clinical Study Reports (CSRs) in compliance with regulatory requirements
- Work with project leads and medical writers to ensure documentation completeness
- Use publishing software to generate electronic submission-ready deliverables
- Insert navigational features such as bookmarks and hyperlinks
- Perform MS Word formatting according to SOPs, client standards, and regulatory guidelines
- Insert and edit tables, figures, and templates as required
- Coordinate draft and final document distribution to teams and clients
- Track timelines and manage deliverables efficiently
2. Quality Control & Compliance
- Conduct thorough quality checks before document distribution
- Ensure documents are submission-ready and aligned with regulatory requirements
- Review draft and final documents prepared by other document specialists under supervision
- Comply with departmental, corporate, and client-specific SOPs
Parexel Hiring Document Specialist I
3. Document Project Management
- Support negotiation of deliverable timelines
- Serve as Document Specialist representative on assigned projects
- Attend study team meetings and coordinate document review processes
- Facilitate publishing through final approval stages
- Organize project files and ensure proper documentation archiving
- Support contractual and financial tracking under management supervision
4. Training & General Responsibilities
- Complete mandatory corporate and departmental training
- Assist in mentoring new team members if required
- Maintain workload trackers and project records
- Provide administrative or document-related support as assigned
- Participate in departmental and company meetings
Eligibility Criteria
Education
- Bachelor’s degree in Health Sciences, Life Sciences, Pharmacy, or related field
OR - Degree in Computer Science / Technology with experience in document processing and publishing
Equivalent regional qualifications may also be considered.
Experience
- Experience in clinical document publishing and formatting preferred
- Proven ability to process 15–17 pages per hour (formatting and post-PDF work)
- Experience handling clinical trial dossiers, Clinical Study Reports (CSRs), and regulatory submission documents
Parexel Hiring Document Specialist I
Technical Skills Required
- Advanced MS Word and MS Office skills
- Strong Adobe Acrobat PDF processing skills
- Experience with document management systems (DMS)
- Familiarity with publishing software tools
- Ability to apply styles, templates, formatting standards, and graphical elements
- High attention to detail and proofreading accuracy
- Basic understanding of medical and pharmaceutical terminology
- Advanced keyboarding and formatting efficiency
Soft Skills
- Excellent written and verbal communication
- Strong interpersonal skills
- Client-focused approach
- Ability to manage multiple tasks simultaneously
- Flexible and adaptable to changing priorities
- Ability to work effectively in a matrix and cross-functional environment
Salary & Benefits
The official job posting does not specify compensation details. Salary and benefits will be offered as per company norms based on qualifications and experience. Parexel Hiring Document Specialist I
Employees at Parexel typically benefit from:
- Remote work flexibility
- Exposure to global regulatory projects
- Structured training and development programs
- Opportunity to work in international clinical teams
- Inclusive and collaborative work culture
Selection Process
The hiring process may include:
- Online Application Submission
- Resume Screening
- Technical Assessment (Formatting/Publishing Skills)
- Interview Round(s)
- HR Discussion and Offer
Shortlisted candidates will be contacted directly by the recruitment team.
Important Dates
- No specified closing date; candidates are advised to apply promptly.
Why Apply for This Clinical Publishing Role?
- Opportunity to work with a globally recognized CRO
- Remote flexibility across major Indian cities
- Hands-on exposure to clinical study report publishing
- Career growth in regulatory documentation and submission management
- Strong pathway into advanced regulatory publishing and medical writing support roles
- Experience in submission-ready documentation aligned with international standards
This role is particularly suitable for professionals aiming to build a long-term career in regulatory publishing, clinical documentation, and global submission support. Parexel Hiring Document Specialist I
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform providing pharmaceutical and clinical research job updates. We are not affiliated with Parexel or any organization mentioned above. Candidates are advised to apply only through official company channels and verify details before proceeding. Parexel Hiring Document Specialist I
Interested professionals with strong document publishing and formatting expertise are encouraged to apply promptly and advance their career in clinical regulatory documentation. Parexel Hiring Document Specialist I
