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Senior Medical Writer

Syneos Health
Syneos Health
3-5 years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. 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, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Senior Medical Writer – Remote Medical Writing Jobs in India | Regulatory & Scientific Writing | Syneos Health

Location: Remote, India
Company: Syneos Health
Job Type: Full-Time
Work Mode: Remote
Department: Medical Writing / Regulatory Writing / Scientific Communications
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 that partners with pharmaceutical, biotechnology, and healthcare innovators across the complete drug development and commercialization lifecycle. With expertise spanning clinical development, regulatory affairs, pharmacovigilance, medical communications, and scientific documentation, Syneos Health offers strong growth opportunities for experienced healthcare and life sciences professionals.

This role is ideal for professionals seeking advanced careers in medical writing, regulatory documentation, scientific communications, publication writing, and pharmaceutical clinical documentation.


Job Overview

Syneos Health is hiring a Senior Medical Writer for a remote India-based opportunity. This position is ideal for experienced medical writing professionals with expertise in clinical regulatory writing, scientific documentation, medical communications, publication development, and regulatory submission support.

The selected candidate will lead end-to-end medical writing deliverables across global clinical development programs, ensuring scientific clarity, regulatory compliance, document quality, and timely delivery.

This is an excellent opportunity for professionals looking to advance their careers in remote medical writing, clinical documentation leadership, and pharmaceutical scientific communications.


Key Responsibilities

Medical & Regulatory Writing

  • Lead the development, review, and delivery of high-quality medical writing documentation with scientific accuracy and regulatory compliance.
  • Prepare and manage a wide range of medical and regulatory documents, 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 Documentation
    • NDA / eCTD Submission Content
    • 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
    • Sponsor standards
    • Internal SOPs
    • Approved templates and documentation guidelines
  • Maintain submission-ready document quality and consistency.

Scientific Review & Editorial Quality

  • Coordinate quality review, editorial review, and scientific consistency assessments.
  • Act as peer reviewer for medical writing deliverables.
  • Review statistical analysis plans and TLF specifications for content alignment, clarity, and formatting consistency.
  • Ensure proper management of source documentation.

Cross-Functional Collaboration

  • Collaborate with:
    • Biostatistics teams
    • Data management teams
    • Regulatory affairs professionals
    • Medical affairs teams
    • Clinical operations stakeholders
    • Sponsor clients
  • Lead document review discussions and client feedback resolution.
  • Maintain strong stakeholder communication throughout project execution.

Scientific Research & Literature Support

  • Conduct online clinical literature research and evidence review.
  • Ensure copyright-compliant scientific referencing and publication support.
  • Support evidence-based content development.

Leadership & Mentorship

  • Mentor junior and mid-level medical writers.
  • Provide writing guidance, technical consultation, and document development support.
  • Support internal training, process improvement, and documentation standardization initiatives.

Project Delivery & Budget Management

  • Deliver projects within assigned timelines and budgeted hours.
  • Communicate project progress, risks, and scope changes to leadership.
  • Complete administrative and operational deliverables on schedule.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Medicine
    • Biomedical Sciences
    • Clinical Research
    • Allied healthcare disciplines
  • 3–5 years of relevant medical, scientific, or technical writing experience
  • Experience in:
    • Biopharmaceutical companies
    • Medical device organizations
    • Contract Research Organizations (CROs)
  • Strong expertise in:
    • FDA regulations
    • ICH guidelines
    • Clinical regulatory documentation
    • Publication best practices
    • Medical writing standards
  • Strong command of written English
  • Excellent grammar and scientific communication skills
  • Familiarity with AMA Manual of Style

Preferred Skills

  • Medical writing
  • Regulatory writing
  • Clinical study report writing
  • IND / NDA submissions
  • eCTD documentation
  • Scientific publication writing
  • Medical communications
  • Patient narrative writing
  • Investigator brochure development
  • FDA / ICH compliance
  • Literature review
  • Medical editing
  • Scientific document leadership