Medical Writer II – CSR Narrative | Gurugram, India (Hybrid)
Location: Gurugram, Haryana, India
Job Type: Full-Time | Hybrid
Experience Required: 1–3 years in CSR narrative authoring
Job ID: 25105488
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating client success across clinical development, medical affairs, and commercial services. Our innovative approach centers on patients and clients, combining scientific expertise with operational excellence to deliver transformative therapies worldwide.
With 29,000 employees across 110 countries, Syneos Health fosters a culture of collaboration, innovation, and professional development. Our commitment to diversity, equity, and inclusion ensures an environment where every employee can thrive and contribute meaningfully to improving global health outcomes.
Role Overview
As a Medical Writer II – CSR Narrative, you will play a pivotal role in developing high-quality clinical study report (CSR) narratives and other medical writing deliverables. You will work closely with cross-functional teams, including biostatistics, regulatory affairs, clinical operations, and medical affairs, to deliver accurate, clear, and compliant documentation aligned with ICH, FDA, and company standards.
This position requires 1–3 years of medical writing experience, specifically in CSR narrative development. The role is hybrid-based in Gurugram, offering opportunities to collaborate across global teams while contributing to key clinical documentation initiatives.
Key Responsibilities
Author, compile, edit, and review CSR narratives with minimal supervision.
Mentor junior medical writers and provide guidance on document standards and regulatory compliance.
Support development of clinical study documents, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Patient narratives
Investigator brochures
Annual reports
Review statistical analysis plans, tables, listings, and figures for accuracy, consistency, and format.
Ensure adherence to regulatory guidelines, including ICH-E3, FDA, and client-specific standards, while meeting timelines and budgets.
Conduct literature searches to support medical writing deliverables.
Collaborate with project teams to clarify data, resolve queries, and ensure scientific accuracy.
Maintain awareness of project budgets and adhere to allocated hours.
Perform peer review of internal writing deliverables to ensure quality and compliance.
Minimal travel (<25%) may be required.
Required Qualifications
Education: Postgraduate degree preferred (MSc, MPharm, or equivalent).
Experience: 1–3 years of medical writing experience, specifically in CSR narrative authoring.
Strong knowledge of English grammar, FDA and ICH guidelines, and familiarity with AMA style guide.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), email, and internet research.
Working knowledge of clinical research principles, drug development process, and regulatory requirements.
Strong interpersonal, communication, and proofreading skills with a high degree of independence.
Detail-oriented, organized, and capable of managing multiple projects simultaneously.
Why Join Syneos Health
Be part of a global, collaborative team driving innovation in clinical development.
Gain exposure to high-impact projects supporting FDA-approved drugs and EMA-authorized products.
Continuous learning through career development programs, technical training, and mentorship.
Inclusive culture that values diversity of thought and encourages authentic contribution.
Over the past five years, Syneos Health has supported 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 clinical studies across 73,000 sites globally.
How to Apply
Interested candidates with the required experience are encouraged to apply today and contribute to transformative clinical research initiatives.
Gujarat :
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Peru | Argentina |Brazil :
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