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Medical Writer Ii (Csr Narratives)

1-2 years
Not Disclosed
10 Oct. 19, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 Narratives)

📅 Updated: October 15, 2025
📍 Location: India – Gurugram (Hybrid)
🆔 Job ID: 25102321


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes.

Culture & Values:

  • Career development, technical/therapeutic training, peer recognition, and total rewards.

  • Total Self culture: encourages authenticity, inclusion, and belonging.

  • Collaboration, innovation, and agility to enhance therapy delivery and client satisfaction.

Global Impact:

  • Engaged with 94% of novel FDA-approved drugs and 95% EMA-authorized products.

  • Managed 200+ studies across 73,000+ sites with 675,000+ trial patients.


Role Purpose

Supports medical writing projects focused on Clinical Study Reports (CSR) narratives. Develops, edits, and reviews regulatory and clinical documents with minimal supervision while mentoring junior writers.


Key Responsibilities

Medical Writing & Document Development

  • Drafts, compiles, and edits medical writing deliverables, including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Annual reports

    • Investigator brochures

  • Reviews statistical analysis plans and TFL (Table/Figure/Listing) specifications for accuracy and consistency.

  • Performs online clinical literature searches as needed.

  • Ensures adherence to regulatory standards (ICH-E3), SOPs, client guidelines, and approved templates.

Collaboration & Review

  • Interacts with data management, biostatistics, regulatory, and medical affairs teams.

  • Serves as peer reviewer to ensure clarity, scientific accuracy, consistency, and proper formatting.

  • Supports mentoring of less experienced medical writers.

Project Management & Compliance

  • Maintains awareness of project budgets and communicates deviations.

  • Completes administrative tasks within specified timelines.

  • Minimal travel (<25%) as required.


Qualifications & Experience

  • Education: Master’s degree (M.Pharm) or Bachelor’s degree in life sciences.

  • Experience:

    • Master’s: Minimum 1 year in narrative writing

    • Bachelor’s: Minimum 2 years in narrative writing

  • Skills & Knowledge:

    • Strong proficiency in Word, Excel, PowerPoint, email, and Internet

    • Extensive knowledge of English grammar, FDA/ICH regulations, AMA style guide

    • Familiarity with principles of clinical research, drug development, and regulatory guidelines

    • Independent, detail-oriented, team-oriented, with leadership and presentation skills


Core Competencies

  • Effective scientific and clinical data analysis

  • Professionalism and ownership of work

  • Commitment to high-quality output

  • Proactivity, enthusiasm, and teamwork

  • Strong interpersonal and client-relationship skills


Additional Information

  • Responsibilities may evolve; company may assign additional tasks at its discretion.

  • Equivalent experience, skills, or education may be considered.

  • Compliant with Americans with Disabilities Act; reasonable accommodations provided.

  • Opportunity to join the Talent Network for future career opportunities.


Summary

Medical Writer II (CSR Narratives) plays a crucial role in drafting, editing, and reviewing clinical study documents and narratives, supporting regulatory compliance while collaborating with cross-functional teams and mentoring junior writers.