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Sr Medical Writer (Authoring Csr Narratives)

0-2 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Remote 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

 

Job Title: Senior Medical Writer (Authoring CSR Narratives)

Updated: April 28, 2025
Location: India (Home-Based, Asia-Pacific)
Job ID: 25002558
Company: Syneos Health


Position Summary

Syneos Health is seeking a Senior Medical Writer to lead the development of high-quality clinical documents, particularly Clinical Study Reports (CSRs) and patient narratives. This role involves mentoring junior writers, overseeing complex writing projects, and ensuring regulatory compliance with ICH, FDA, and client-specific guidelines. The ideal candidate will have expertise in clinical research, a strong understanding of medical writing standards, and excellent leadership skills to drive projects to completion within specified timelines and budgets.


Key Responsibilities

  • Lead the creation and review of complex documents including CSRs, clinical protocols, patient narratives, IND submissions, NDA/eCTD submissions, and integrated summary reports.

  • Mentor and guide less experienced writers on complex writing tasks and provide leadership on project timelines and deliverables.

  • Work closely with departments like biostatistics, regulatory affairs, and data management to produce high-quality writing outputs.

  • Review statistical analysis plans and table/figure/listing specifications to ensure accuracy and consistency in content.

  • Ensure adherence to regulatory standards (ICH E3, FDA guidelines) and client templates during all medical writing projects.

  • Perform literature searches and maintain awareness of evolving industry practices, guidelines, and regulatory requirements.

  • Maintain project budget adherence and ensure timely communication of any deviations.

  • Collaborate with internal review teams and clients to finalize documents and ensure clarity, accuracy, and compliance.


Required Qualifications

  • Education: Bachelor's degree in a scientific or medical field (or Bachelor's degree in English, Communications, or Social Sciences with relevant medical knowledge).

  • Experience:

    • Extensive experience in medical writing, particularly in clinical study reports (CSRs) and related clinical documents.

    • Strong understanding of FDA, ICH guidelines, and AMA style guide.

    • Demonstrated ability to lead writing projects independently and mentor junior writers.

  • Skills:

    • Expertise in Word, Excel, PowerPoint, email, and Internet-based research tools.

    • Strong presentation, proofreading, and interpersonal skills.

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


Why Join Syneos Health

  • Join a global leader working with 94% of FDA-approved novel drugs and 95% of EMA-authorized products.

  • Engage in diverse and innovative projects that change lives, working with a dynamic team across 110 countries.

  • Foster professional development through a supportive and engaging work environment that promotes continuous growth.