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Senior Medical Writer (Csr, Ib , Protocol)

5+ years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Medical Writer (CSR, IB, Protocol) – Remote India | Syneos Health

Job Summary

Syneos Health is seeking an experienced Senior Medical Writer to lead regulatory and scientific document creation including Clinical Study Reports (CSR), Investigator Brochures (IB), and protocols. This remote role in India is ideal for professionals with 5+ years of medical writing experience in the pharmaceutical or CRO industry. The position involves independent project leadership, regulatory compliance, cross-functional collaboration, and mentoring.


Key Responsibilities

  • Write and manage clinical study documents: protocols, CSRs, IBs, patient narratives, IND/NDA submissions, etc.

  • Adhere to ICH E3, company SOPs, and client templates and standards

  • Coordinate internal reviews and ensure high-quality, scientifically accurate content

  • Serve as subject matter expert and peer reviewer for complex regulatory deliverables

  • Interpret clinical data, perform literature reviews, and ensure copyright compliance

  • Collaborate with cross-functional teams in clinical, regulatory, biostatistics, and data management

  • Review and refine statistical outputs and ensure document consistency

  • Lead medical writing efforts across studies and manage multiple deliverables

  • Mentor junior writers and contribute to knowledge sharing


Required Skills & Qualifications

  • Bachelor’s degree in life sciences or medical-related field; graduate degree preferred

  • Minimum 5 years of relevant experience in medical or scientific writing

  • Strong knowledge of ICH-GCP, FDA regulations, and regulatory document standards

  • Experience with submissions to global regulatory agencies (e.g., IND, NDA, eCTD)

  • Proficiency in Microsoft Office and AMA Manual of Style

  • Strong command of medical terminology and ability to synthesize clinical data

  • Excellent attention to detail, time management, and communication skills

  • Prior experience in a CRO or biopharma setting highly desirable


Perks & Benefits

  • Fully remote role with flexible work hours

  • Competitive salary and performance-based incentives

  • Opportunities for global project exposure

  • Career development programs and mentorship

  • Diverse, inclusive, and collaborative company culture

  • Employee recognition and rewards programs


Company Description

Syneos Health is a leading global provider of fully integrated biopharmaceutical solutions. Working across 110+ countries, Syneos has contributed to 94% of all novel FDA approvals in the past five years. With a strong focus on clinical development, commercial insights, and patient engagement, the company is committed to accelerating drug delivery and transforming global healthcare.


Work Mode

Remote – India


Call-to-Action

Ready to make a global impact in medical writing? Join Syneos Health as a Senior Medical Writer and help shape the future of clinical research.
Apply now and advance your career in regulatory writing.