Medical Writer II (CSR Narrative)
Location: Gurgaon, Haryana, India
Job ID: 25105488-OTHLOC-5206-2DH
Company: Syneos Health
Industry: Clinical Research / Medical Writing / Biopharmaceutical Services
Employment Type: Full-Time
Experience Required: 1–3 Years (Medical Writing – CSR Narrative)
Updated: February 10, 2026
Job Overview
Syneos Health is seeking a detail-oriented Medical Writer II (CSR Narrative) to join its Clinical Development team in Gurgaon, India. This role involves authoring and reviewing clinical and regulatory documents, with a strong focus on Clinical Study Report (CSR) narratives. The ideal candidate will have experience in clinical research documentation, regulatory compliance, and scientific communication, along with the ability to work collaboratively across cross-functional teams.
Syneos Health is a globally recognized biopharmaceutical solutions organization that integrates clinical, medical affairs, and commercial expertise to accelerate therapy development and improve patient outcomes across international markets.
Key Responsibilities
Develop, compile, write, and edit medical writing deliverables with minimal supervision
Author Clinical Study Report (CSR) narratives and related clinical documentation
Prepare and support development of clinical study protocols, protocol amendments, investigator brochures, and annual reports
Create and review patient narratives and clinical study reports ensuring scientific accuracy and clarity
Review statistical analysis plans, tables, figures, and listings for accuracy, format, and consistency
Ensure compliance with regulatory standards including ICH-E3 guidelines, FDA regulations, and company SOPs
Collaborate with cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs
Perform peer review of medical writing deliverables and address feedback effectively
Conduct clinical literature searches and support evidence-based documentation
Mentor junior medical writers when required
Maintain awareness of drug development processes and evolving regulatory requirements
Manage project timelines and work within assigned budgets
Complete administrative tasks within specified timelines
Participate in continuous professional development activities
Travel requirements may be minimal (less than 25%)
Eligibility Criteria and Skills Required
Postgraduate degree preferred in Life Sciences, Pharmacy, Medicine, or related discipline
1–3 years of professional experience in medical writing with CSR narrative authoring experience
Strong understanding of clinical research principles and drug development processes
Knowledge of FDA, ICH guidelines, and AMA style guide
Excellent written and verbal communication skills in English
Strong proofreading, presentation, and scientific interpretation skills
Ability to analyze and present complex clinical data effectively
Proficiency in Microsoft Word, Excel, PowerPoint, and internet-based research tools
Strong interpersonal skills and ability to work in a collaborative team environment
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization operating across 110 countries with over 29,000 employees. The organization accelerates clinical development and commercialization by delivering innovative solutions that improve healthcare outcomes globally. Over the past five years, Syneos Health has supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products, contributing to more than 200 studies across 73,000 sites and over 675,000 clinical trial patients.
The company is committed to employee development, diversity, and a collaborative work culture that supports innovation and professional growth.
Uttar Pradesh :
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