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Medical Writer Ii (Csr Narrative)

Syneos Health
Syneos Health
1-3 years
Not Disclosed
India
10 Feb. 12, 2026
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Medical Writer II (CSR Narrative) – Remote

Updated: February 10, 2026
Location: India (Remote)
Job ID: 25105488
Company: Syneos Health
Experience Required: 1–3 Years in Medical Writing (CSR Narrative Authoring)

Job Overview

Syneos Health is a leading global biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes through integrated clinical, medical affairs, and commercial expertise. The organization operates across more than 110 countries and is committed to delivering innovative healthcare solutions by placing patients and customers at the center of its operations.

The Medical Writer II (CSR Narrative) role involves developing high-quality clinical and regulatory documentation, including Clinical Study Report (CSR) narratives and other medical writing deliverables. This position requires strong scientific writing expertise, knowledge of regulatory standards, and collaboration with cross-functional teams to support clinical research and drug development activities.

This is a remote opportunity designed for professionals with experience in clinical documentation, regulatory writing, and clinical data interpretation.

Key Responsibilities

  • Author, compile, edit, and review medical writing deliverables with minimal supervision.

  • Develop Clinical Study Report (CSR) narratives and related clinical and regulatory documents.

  • Prepare and support documentation including clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures.

  • Mentor junior medical writers and provide project-related guidance when required.

  • Review statistical analysis plans and table, figure, and listing specifications to ensure accuracy, consistency, and quality.

  • Collaborate with cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs.

  • Perform peer review of documents and address feedback to ensure scientific accuracy and clarity.

  • Ensure compliance with regulatory standards including ICH-E3 guidelines, company SOPs, client standards, and approved templates.

  • Conduct clinical literature searches to support document development.

  • Interpret and present complex clinical data in a structured and clear manner.

  • Monitor project timelines, deliverables, and budget requirements.

  • Maintain knowledge of evolving regulatory guidance and industry best practices in medical writing.

  • Complete administrative and project-related tasks within defined timelines.

  • Perform additional responsibilities as assigned.

  • Minimal travel may be required (less than 25%).

Eligibility Criteria and Qualifications

Education: Postgraduate degree preferred in Life Sciences, Pharmacy, Medicine, or a related field.

Experience: Minimum 1–3 years of professional experience in medical writing with mandatory experience in CSR narrative authoring.

Technical and Professional Requirements:

  • Strong command of English grammar and scientific writing principles.

  • Knowledge of FDA regulations, ICH guidelines, and familiarity with AMA style guide.

  • Understanding of clinical research processes and drug development lifecycle.

  • Ability to interpret clinical data and present complex information effectively.

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and internet applications.

  • Strong proofreading, presentation, and leadership capabilities.

  • Ability to work independently in a remote environment while maintaining team collaboration.

Core Competencies

  • Excellent written and verbal communication skills.

  • Strong analytical and problem-solving abilities.

  • High attention to detail and accuracy.

  • Effective time management and organizational skills.

  • Ability to manage multiple projects and meet deadlines.

Why Join Syneos Health

Syneos Health provides a collaborative work environment focused on career development, technical training, and professional growth. The organization promotes an inclusive culture that values diversity, innovation, and employee well-being while contributing to global healthcare advancements.

Over the past five years, Syneos Health has supported 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites involving more than 675,000 clinical trial participants.