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Medical Writer I (Junior Project Specialist) – Medical Writing

Syneos Health
Syneos Health
0-2 years
preferred by company
Gurgaon, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing

Medical Writer I (Junior Project Specialist) – Medical Writing Jobs in Gurugram | Hybrid | 1-Year Contract

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


About the Company

Syneos Health is a globally recognized biopharmaceutical solutions and clinical research organization supporting pharmaceutical, biotechnology, and healthcare companies across the complete drug development lifecycle. Known for delivering excellence in clinical operations, regulatory solutions, pharmacovigilance, and medical communications, Syneos Health offers outstanding opportunities for healthcare and life sciences professionals seeking global exposure.

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


Job Overview

Syneos Health is hiring a Medical Writer I (Junior Project Specialist) for its Gurugram hybrid office location on a 1-year contract basis. This opportunity is ideal for freshers and early-career professionals with 0–2 years of relevant experience in medical writing, regulatory documentation, clinical operations, or life sciences support functions.

The selected candidate will support document management, eTMF filing, Veeva RIM operations, regulatory documentation workflows, metadata validation, project tracking, and compliance-driven document control activities.

This role is highly suitable for candidates seeking careers in medical writing, regulatory affairs, clinical documentation, trial master file management, and pharmaceutical document operations.


Key Responsibilities

Medical Documentation & eTMF Management

  • Support electronic Trial Master File (eTMF) document filing activities in compliance with sponsor and regulatory requirements.
  • Perform document classification, organization, and compliant filing within Veeva RIM / Veeva systems.
  • Ensure accurate indexing, metadata validation, and document placement in designated repository structures.
  • Maintain document quality, completeness, integrity, and retrieval readiness.

Veeva Document Operations

  • Download, review, categorize, and upload regulatory and clinical documentation into Veeva platforms.
  • Follow approved naming conventions and document classification protocols.
  • Ensure proper electronic document archival and secure storage practices.
  • Support structured digital document lifecycle management.

Regulatory Compliance & Quality Management

  • Ensure document filing activities align with GxP guidelines, FDA requirements, EU regulatory expectations, and sponsor SOPs.
  • Review documentation for quality compliance prior to final filing.
  • Maintain audit-ready document control processes.
  • Support compliance with evolving regulatory standards and internal process controls.

Project Coordination & Timeline Management

  • Track project documentation and maintain accurate document status records.
  • Support timely delivery of assigned documentation milestones.
  • Notify project leads or supervisors when deliverables are at risk.
  • Maintain operational workflow consistency and deadline adherence.

Clinical & Research Documentation Support

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

Process Improvement & Collaboration

  • Contribute to workflow optimization, SOP refinement, and documentation process improvements.
  • Participate in internal and client-facing project meetings.
  • Collaborate with stakeholders to resolve documentation comments and operational queries.
  • Maintain professional communication with internal teams and client stakeholders.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Clinical Research
    • Biomedical Sciences
    • Medicine
    • Allied Healthcare disciplines
  • Basic understanding of:
    • Medical writing principles
    • Clinical documentation workflows
    • eTMF processes
    • Regulatory documentation standards
    • GxP compliance
    • Digital document management
  • Strong written communication skills
  • Excellent organizational and documentation abilities
  • High attention to detail
  • Ability to manage multiple tasks in deadline-driven environments
  • Strong learning mindset and adaptability