Job Title
Medical Writer I (Junior Project Specialist – 1-Year Contract)
Company: Syneos Health
Location: Gurugram, India (Hybrid)
Job ID: 25108568
Updated On: May 21, 2026
Company Overview
Syneos Health is a fully integrated life sciences services organization focused on accelerating drug development and commercialization. The company works with pharmaceutical innovators across the full development lifecycle to improve healthcare outcomes globally.
The organization emphasizes:
Career development and continuous learning
Inclusive and collaborative work culture
Innovation in clinical and regulatory solutions
Strong global impact in healthcare and clinical research
Role Summary
The Medical Writer I (Junior Project Specialist) supports document management and regulatory filing activities within clinical and medical projects. The role focuses on accurate handling of clinical documentation in systems such as Veeva RIM and eTMF, ensuring compliance with global regulatory standards and GxP guidelines.
Key Responsibilities
1. Document Management & Filing
Work within Veeva RIM systems as per client requirements
Perform eTMF filing activities including TMP filing understanding
Upload, download, classify, and store documents accurately in Veeva
Ensure correct naming conventions and metadata validation
Categorize documents for easy retrieval and systematic organization
2. Compliance & Quality Control
Ensure all documents meet required quality and integrity standards
Follow GxP guidelines and regulatory requirements (FDA, EU, etc.)
Maintain secure and compliant electronic document archiving
Verify proper document placement within systems
3. Project Tracking & Coordination
Track project documents and maintain updated records
Support project timelines and ensure milestone adherence
Report delays or risks to project leads or managers
Participate in internal and client meetings when required
4. Regulatory & Study Support
Understand filing scope including:
Early Access Programs
External Research Projects
Observational and Non-Interventional Studies
Support adherence to sponsor and regulatory expectations
5. Process Improvement
Contribute to development of workflows and SOPs
Adapt to evolving operational requirements
Support continuous process improvement initiatives
6. Communication & Collaboration
Work with client stakeholders and internal teams
Support resolution of document-related queries
Demonstrate proactive learning and strong communication skills
Required Skills & Competencies
Familiarity with Veeva RIM and/or Veeva Clinical systems
Understanding of eTMF processes and TMP filing
Basic knowledge of GxP guidelines
Strong attention to detail
Ability to manage documentation accurately
Good communication and coordination skills
Willingness to learn stakeholder management
Preferred Attributes
Exposure to regulatory or clinical documentation workflows
Understanding of FDA, EU, and global regulatory standards
Experience in digital document archiving systems
Ability to work in fast-paced, deadline-driven environments
Key Soft Skills
Detail-oriented mindset
Proactive learning attitude
Strong organizational skills
Time management and deadline adherence
Team collaboration
Additional Notes
Responsibilities may be updated or expanded as needed by the company
Equivalent skills/experience may be considered
Role does not constitute a fixed employment contract
Compliance with disability accommodation laws is ensured where applicable
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