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Senior Medical Writer – Clinical & Regulatory Medical Writing

Syneos Health
Syneos Health
3-5 years
Not Disclosed
Remote, India, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Senior Medical Writer – Clinical & Regulatory Medical Writing

Company: Syneos Health
Job Title: Senior Medical Writer
Location: Remote – India
Job ID: 25108453
Department: Clinical Solutions / Medical Writing


About the Role

Syneos Health is hiring a Senior Medical Writer for its global clinical and regulatory writing team. This remote opportunity is ideal for professionals experienced in Medical Writing, Clinical Documentation, Regulatory Submissions, Scientific Writing, and Clinical Research Communication.

The selected candidate will lead medical writing deliverables across clinical studies, regulatory documentation, publications, and scientific communications while ensuring compliance with global regulatory standards and industry best practices.

This role is best suited for candidates with 3–5 years of experience in Medical Writing within the biopharmaceutical, medical device, or CRO industry.


Key Responsibilities

Medical Writing & Scientific Documentation

  • Lead preparation and completion of medical writing deliverables
  • Ensure scientific information is presented clearly, accurately, and compliantly
  • Manage medical writing activities across individual clinical studies
  • Coordinate medical writing deliverables across multiple departments with minimal supervision
  • Lead resolution of client review comments and document revisions

Clinical & Regulatory Writing

Prepare and manage documentation including:

  • Clinical Study Protocols
  • Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Patient Narratives
  • Investigator Brochures
  • Informed Consent Forms (ICFs)
  • Periodic Safety Update Reports (PSURs)
  • Clinical Development Plans
  • IND Submissions
  • NDA & eCTD Submissions
  • Integrated Summary Reports
  • Plain Language Summaries
  • Journal Manuscripts
  • Scientific Abstracts, Posters, and Presentations

Regulatory Compliance & Quality Management

  • Ensure adherence to:
    • ICH E3 Guidelines
    • FDA Regulations
    • Good Publication Practices
    • Company SOPs and client standards
  • Coordinate quality control and editorial reviews
  • Manage source documentation appropriately
  • Review documents for:
    • Scientific accuracy
    • Clarity
    • Consistency
    • Formatting compliance

Cross-Functional Collaboration

  • Collaborate with:
    • Biostatistics
    • Data Management
    • Regulatory Affairs
    • Medical Affairs teams
  • Review statistical analysis plans and table/figure/listing specifications
  • Provide feedback to improve statistical outputs and document requirements
  • Build strong client and stakeholder relationships

Literature Research & Process Improvement

  • Conduct online clinical and scientific literature searches
  • Ensure compliance with copyright and publication requirements
  • Identify process improvement opportunities and propose solutions
  • Contribute to development of internal training materials and process enhancements

Leadership & Mentorship

  • Mentor and guide junior medical writers on complex projects
  • Provide technical consultation and support to internal teams
  • Support departmental capability development
  • Manage project timelines, priorities, and budgeted writing hours

Educational Qualification

Candidates with backgrounds in the following areas are preferred:

  • Life Sciences
  • Pharmacy
  • Medicine
  • Clinical Research
  • Biotechnology
  • Healthcare or related scientific disciplines

Required Experience

  • 3 to 5 years of relevant experience in:
    • Medical Writing
    • Scientific Writing
    • Regulatory Writing
    • Clinical Documentation
    • Healthcare or Life Sciences Communication

Industry Experience Required

Candidates should have prior experience within:

  • Biopharmaceutical Industry
  • Medical Device Industry
  • Contract Research Organizations (CROs)