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Medical Writer Ii (Csr Narratives)

Syneos Health
Syneos Health
1-2 years
Not Disclosed
Aachen, Abbott Park, Aberdeen, Europe
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: 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: supports authenticity, inclusion, and belonging.

  • Emphasis on collaboration, innovation, and agility to improve therapy delivery and client outcomes.

Global Impact:

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

  • Conducted 200+ studies across 73,000+ sites involving 675,000+ trial patients.


Job Purpose

Responsible for authoring, reviewing, and editing Clinical Study Reports (CSRs), patient narratives, and other medical writing deliverables. Mentors junior writers and ensures compliance with regulatory guidelines and client standards.


Key Responsibilities

Medical Writing & Content Development

  • Compile, write, and edit medical writing deliverables with minimal supervision.

  • Develop/support documents including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Annual reports

    • Investigator brochures

  • Review statistical analysis plans and TFL (Tables, Figures, Listings) specifications for content, grammar, format, and consistency.

  • Conduct online clinical literature searches as applicable.

  • Adhere to ICH-E3 guidelines, client standards, SOPs, and approved templates.

Collaboration & Mentorship

  • Interact with data management, biostatistics, regulatory, and medical affairs teams to ensure document accuracy.

  • Serve as peer reviewer and address team comments to ensure scientific clarity and consistency.

  • Mentor less experienced medical writers as needed.

Project Management & Compliance

  • Manage assigned projects within budgeted hours.

  • Track timelines, communicate changes, and complete administrative tasks on schedule.

  • Minimal travel required (<25%).


Qualifications & Experience

  • Education: Postgraduate degree (Master/MPharm) or Bachelor’s degree in relevant field.

  • Experience:

    • ≥1 year of narrative experience with postgraduate qualification

    • ≥2 years with graduate qualification

  • Demonstrated proficiency in drafting, reviewing, and editing narratives.

  • Strong knowledge of English grammar, FDA and ICH regulations, and AMA style guide.

  • Familiarity with clinical research principles and ability to interpret and present complex clinical data.

  • Proficiency in MS Word, Excel, PowerPoint, email, and internet.


Core Competencies

  • High degree of independence, professionalism, and team orientation.

  • Effective presentation, proofreading, interpersonal, and leadership skills.

  • Strong attention to detail, accuracy, and quality of outputs.

  • Ability to work collaboratively in cross-functional teams.


Additional Information

  • Responsibilities may evolve; company may assign additional tasks as needed.

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

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

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


Summary

The Medical Writer II (CSR Narratives) produces high-quality clinical writing deliverables, including CSRs and patient narratives, while mentoring junior writers, ensuring regulatory compliance, and supporting cross-functional teams.