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Senior Medical Writer

Syneos Health
Syneos Health
3-5 years
preferred by company
Gurugram, India
1 May 18, 2026
Job Description
Job Type: Hybrid 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

Senior Medical Writer – Medical Writing Jobs in Gurugram | Hybrid Clinical Research Opportunity | Syneos Health

Location: Gurugram, India (Hybrid)
Company: Syneos Health
Job Type: Full-Time
Work Mode: Hybrid
Department: Medical Writing / Regulatory Writing / Clinical Documentation
Experience Required: 3–5 years of relevant medical, scientific, or technical writing experience
Job ID: 25108453


About the Company

Syneos Health is a globally recognized clinical research organization (CRO) and biopharmaceutical solutions company supporting pharmaceutical, biotechnology, and healthcare innovators across the complete drug development and commercialization lifecycle. With expertise spanning clinical research, regulatory affairs, pharmacovigilance, medical communications, and biostatistics, Syneos Health offers strong career growth opportunities for experienced healthcare professionals.

This role is ideal for professionals seeking advancement in medical writing, regulatory writing, clinical documentation, publication writing, and scientific communication within the pharmaceutical and CRO industry.


Job Overview

Syneos Health is hiring a Senior Medical Writer for its Gurugram hybrid office. This opportunity is designed for experienced medical writing professionals with expertise in clinical regulatory writing, scientific documentation, publication development, clinical study reporting, and sponsor-facing document management.

The selected candidate will lead high-quality medical writing deliverables across clinical development programs, ensuring scientific accuracy, regulatory compliance, and timely submission of key medical and regulatory documentation.

This is an excellent opportunity for professionals seeking senior-level careers in medical writing, clinical documentation leadership, regulatory submissions, and pharmaceutical scientific communications.


Key Responsibilities

Medical & Regulatory Writing

  • Lead preparation, development, and delivery of high-quality medical writing documents, ensuring scientific accuracy, clarity, and regulatory compliance.
  • Create and manage documentation including:
    • Clinical Study Protocols
    • Protocol Amendments
    • Clinical Study Reports (CSRs)
    • Patient Narratives
    • Investigator Brochures (IBs)
    • Informed Consent Forms (ICFs)
    • Annual Reports
    • Plain Language Summaries
    • Periodic Safety Update Reports (PSURs)
    • Clinical Development Plans
    • IND Submission Documents
    • NDA / eCTD Submission Documentation
    • Integrated Summary Reports
    • Journal Manuscripts
    • Scientific Abstracts
    • Posters
    • Conference Presentations

Regulatory Compliance & Documentation Standards

  • Ensure all deliverables comply with:
    • FDA regulations
    • ICH guidelines (including ICH E3)
    • Good publication practices
    • Client standards
    • Internal SOPs
    • Approved templates and formatting requirements
  • Maintain consistency, scientific accuracy, and submission readiness across documents.

Cross-Functional Collaboration

  • Collaborate with:
    • Biostatistics teams
    • Data management teams
    • Regulatory affairs teams
    • Medical affairs teams
    • Clinical operations stakeholders
    • Sponsor representatives
  • Coordinate medical writing activities across departments.
  • Lead client comment resolution and document feedback management.

Quality Review & Editorial Oversight

  • Coordinate editorial review, quality review, and scientific consistency checks.
  • Act as peer reviewer for internal writing teams.
  • Review statistical analysis plans and TFL specifications for content relevance and documentation alignment.
  • Ensure source documentation is properly managed.

Scientific Research & Literature Support

  • Conduct clinical literature searches and evidence gathering.
  • Ensure copyright-compliant scientific reference usage.
  • Support scientifically accurate content development.

Leadership & Mentorship

  • Mentor junior medical writers and support capability development.
  • Provide technical consultation, process support, and writing guidance.
  • Contribute to process improvements, templates, internal documentation standards, and training initiatives.

Project & Budget Management

  • Manage assigned writing deliverables within timelines and budgeted hours.
  • Communicate project progress, risks, and timeline impacts to leadership.
  • Complete required administrative and operational documentation.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Medicine
    • Biomedical Sciences
    • Clinical Research
    • Related healthcare disciplines
  • 3–5 years of relevant medical, scientific, or technical writing experience
  • Experience in:
    • Biopharmaceutical industry
    • Medical device industry
    • Contract Research Organization (CRO) environment
  • Strong understanding of:
    • FDA regulations
    • ICH guidelines
    • Regulatory documentation standards
    • Publication best practices
    • Clinical development documentation
  • Strong command of English grammar and professional scientific writing
  • Familiarity with AMA Manual of Style