Medical Writer I (Junior Project Specialist – 1 Year Contract)
Company: Syneos Health
Location: IND – Remote
Job ID: 25108568
Employment Type: Contract (1 year)
Updated On: Yesterday
Company Overview
Syneos Health is a global life sciences services organization that supports drug development and commercialization. It works across clinical research, regulatory affairs, and medical communications to help pharmaceutical companies bring therapies to market efficiently.
Role Summary
The Medical Writer I (Junior Project Specialist) is responsible for:
Supporting document management and regulatory filing processes
Working within Veeva systems (RIM/eTMF) for clinical and regulatory documentation
Ensuring accurate, compliant, and timely document handling in clinical research projects
Supporting GxP-compliant archiving and regulatory documentation workflows
Key Responsibilities
1. Document Management (Veeva Systems)
Work within Veeva RIM / Veeva Clinical systems
Upload, download, and classify regulatory and clinical documents
Ensure correct metadata tagging and document categorization
Maintain accurate and compliant document storage
2. eTMF & Filing Activities
Perform eTMF (electronic Trial Master File) filing tasks
Understand TMP filing requirements and clinical documentation structure
Support filing for:
Early Access Programs
External Research Projects
Observational and Non-Interventional Studies
3. Quality & Compliance
Ensure documents meet quality and integrity standards before filing
Follow GxP guidelines and regulatory requirements
Maintain compliance with FDA, EU, and other global standards
Ensure proper naming conventions and metadata accuracy
4. Digital Archiving & Data Integrity
Ensure secure, systematic, and permanent electronic record storage
Maintain document traceability and audit readiness
Support structured digital archiving processes
5. Project Tracking & Coordination
Track document status and maintain updated project records
Monitor timelines and escalate delays to supervisors or project managers
Support timely completion of documentation deliverables
6. Collaboration & Communication
Participate in internal and client-facing meetings
Communicate effectively with stakeholders and project teams
Assist in resolving document-related queries and comments
Support alignment with client expectations and timelines
7. Process Improvement
Contribute to development of SOPs and workflows
Support continuous improvement of document management processes
Adapt to evolving project and system requirements
Required Skills & Competencies
Technical Skills
Experience with Veeva RIM and/or Veeva Clinical systems
Understanding of eTMF processes and document workflows
Familiarity with GxP guidelines
Basic knowledge of clinical and regulatory documentation
Soft Skills
Strong attention to detail
High level of accuracy in documentation
Strong communication skills
Ability to learn quickly and adapt
Ability to manage multiple tasks and deadlines
Preferred Attributes
Exposure to clinical research or regulatory environments
Understanding of FDA / EU regulatory expectations
Experience in digital document management systems
Willingness to develop stakeholder management skills
Work Environment
Remote role (India-based)
Global clinical operations environment
High-volume document processing and compliance-focused work
Interaction with internal teams and external clients
Role Impact
Ensures regulatory and clinical documentation compliance
Supports audit-ready clinical trial documentation systems
Contributes to smooth execution of global clinical studies
Enables accurate and efficient trial documentation lifecycle management
Career Path Potential
This role can lead to:
Medical Writer
Regulatory Document Specialist
Clinical Operations Specialist
eTMF / Document Management Lead
Regulatory Affairs roles
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Remote, India | Siliguri |Illinois :
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