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.
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