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Medical Writer I (Junior Project Specialist)

Syneos Health
Syneos Health
0-2 years
preferred by company
Remote, India, India
2 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management

Medical Writer I (Junior Project Specialist) – Remote Medical Writing Jobs in India | 1-Year Contract | Syneos Health

Location: Remote, India
Company: Syneos Health
Job Type: Full-Time Contract (1 Year)
Work Mode: Remote
Department: Medical Writing / Regulatory Documentation / Clinical Operations
Experience Required: 0–2 years (Freshers with relevant life sciences or healthcare background may apply)
Job ID: 25108568


About the Company

Syneos Health is a globally established biopharmaceutical solutions and clinical research organization that partners with pharmaceutical, biotechnology, and healthcare companies to accelerate drug development and commercialization. With strong expertise across clinical operations, regulatory affairs, medical communications, and documentation management, the organization offers excellent growth opportunities for healthcare and life sciences professionals.

This role is ideal for candidates seeking careers in medical writing, regulatory documentation, clinical document management, Veeva systems, eTMF operations, and pharmaceutical compliance workflows.


Job Overview

Syneos Health is hiring a Medical Writer I (Junior Project Specialist) for a remote India-based opportunity on a 1-year contract basis. This role is suitable for freshers and professionals with up to 2 years of relevant experience in medical writing, regulatory operations, clinical documentation, or pharmaceutical support functions.

The selected candidate will be responsible for handling eTMF filing, Veeva RIM documentation workflows, metadata validation, regulatory document organization, quality compliance, project documentation tracking, and digital archival support.

This opportunity is especially suitable for professionals looking to build careers in medical writing, clinical documentation, regulatory affairs, and pharmaceutical document management while working remotely.


Key Responsibilities

Medical Documentation & eTMF Operations

  • Support electronic Trial Master File (eTMF) filing activities in compliance with sponsor and regulatory requirements.
  • Manage document organization, classification, and compliant storage within Veeva RIM / Veeva document systems.
  • Ensure accurate document filing based on approved naming conventions and metadata requirements.
  • Maintain document accessibility, retrieval readiness, and organized repository structures.

Veeva Document Management

  • Download documentation from internal systems and upload files accurately into Veeva platforms.
  • Validate metadata and ensure correct document placement.
  • Support document lifecycle control and structured document governance.
  • Ensure document integrity, consistency, and compliance before final filing.

Regulatory Compliance & Quality Control

  • Ensure documentation aligns with:
    • GxP compliance requirements
    • FDA documentation standards
    • EU regulatory expectations
    • Sponsor SOPs and documentation guidelines
  • Maintain audit-ready documentation workflows.
  • Support secure digital archiving and long-term electronic record preservation.
  • Monitor document quality standards and regulatory completeness.

Project Coordination & Documentation Tracking

  • Track assigned project documentation and maintain up-to-date status records.
  • Support project milestone completion and documentation delivery timelines.
  • Escalate risks to Lead Medical Writer, Project Manager, or supervisors when deadlines are at risk.
  • Maintain organized document workflow tracking systems.

Clinical Research Documentation Support

  • Support filing activities for:
    • Early Access Programs
    • External Research Projects
    • Observational Studies
    • Non-Interventional Studies
    • Individual sponsor or regulatory documentation requests

Stakeholder Collaboration & Process Improvement

  • Participate in internal and client-facing project meetings.
  • Collaborate with stakeholders to resolve documentation comments and workflow issues.
  • Contribute to SOP enhancements, process improvements, and workflow optimization initiatives.
  • Demonstrate proactive communication and strong professional collaboration.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Clinical Research
    • Biomedical Sciences
    • Medicine
    • Nursing
    • Allied healthcare disciplines
  • Basic understanding of:
    • Medical writing workflows
    • Clinical documentation practices
    • Regulatory document management
    • eTMF filing
    • Veeva systems
    • GxP compliance
  • Strong written English communication skills
  • Excellent documentation and organizational skills
  • High attention to detail
  • Ability to work independently in remote environments
  • Strong time management and deadline management skills