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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) – Syneos Health – Gurugram, India (Hybrid)

Job Summary

Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Senior Medical Writer for a hybrid role based in Gurugram, India. This opportunity is ideal for experienced professionals in clinical research and regulatory writing. You'll work on Clinical Study Reports (CSR), Investigator Brochures (IB), protocols, and other key scientific documents supporting drug development and regulatory submissions.


Key Responsibilities

  • Lead end-to-end creation and quality review of clinical and regulatory documents

  • Author a variety of deliverables including protocols, CSRs, IBs, safety reports, submission documents, and patient narratives

  • Adhere to ICH E3 guidelines, internal SOPs, and client-specific templates

  • Perform quality and editorial reviews ensuring accuracy and consistency

  • Collaborate with clinical, statistical, regulatory, and data management teams

  • Review statistical outputs (SAP, TFLs) for inclusion in medical documents

  • Conduct literature reviews and ensure compliance with copyright standards

  • Mentor junior medical writers and guide complex projects

  • Contribute to internal process improvements and SOP updates

  • Ensure timely project delivery within allocated budgets


Required Skills & Qualifications

  • Bachelor’s or advanced degree in life sciences, pharmacy, medicine, or related field

  • 5+ years of medical writing experience in pharma, CRO, or life sciences

  • Strong understanding of FDA, ICH-GCP, and regulatory requirements

  • Excellent command of English and familiarity with AMA Manual of Style

  • High proficiency in MS Office tools

  • Experience writing a wide range of regulatory and scientific documents

  • Strong grasp of clinical research principles and medical terminology

  • Excellent project management and peer review skills


Perks & Benefits

  • Competitive compensation and performance bonuses

  • Career advancement and global exposure

  • Access to therapeutic area and technical training

  • Inclusive, diverse work culture focused on well-being

  • Flexible hybrid working model (Gurugram location)

  • Supportive leadership and mentorship opportunities


Company Description

Syneos Health is a leading integrated biopharmaceutical solutions provider, working with 94% of novel FDA-approved drugs. With operations in over 110 countries and a workforce of 29,000+, Syneos delivers customized clinical and commercial solutions to top pharma and biotech companies.


Work Mode

Hybrid – Gurugram, India


Call-to-Action

Ready to advance your career in medical writing? Apply now to become a Senior Medical Writer at Syneos Health and contribute to global clinical development excellence.
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