Medical Writer II – CSR Narrative | Remote, India
Location: Remote, India
Job Type: Full-Time | Remote
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 that accelerates client success through innovative clinical development, medical affairs, and commercial solutions. Our patient- and client-centered model drives efficiencies, simplifies complex processes, and enables the delivery of transformative therapies across the globe.
With 29,000 employees in 110 countries, we foster a culture of collaboration, professional growth, and inclusion. Our Total Self culture encourages employees to bring their authentic selves to work, helping create an environment where diverse ideas and perspectives thrive.
Role Overview
The Medical Writer II – CSR Narrative will develop high-quality clinical study report (CSR) narratives and related medical writing deliverables. This role requires 1–3 years of prior experience in CSR narrative authoring and provides an opportunity to work remotely while collaborating with cross-functional global teams.
You will ensure documents are scientifically accurate, compliant with ICH, FDA, and client standards, and delivered on time and within budget.
Key Responsibilities
Author, edit, and review CSR narratives with minimal supervision.
Mentor junior medical writers on projects as needed.
Support development of clinical study documentation, including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Investigator brochures
Annual reports
Review statistical analysis plans, tables, listings, and figures for clarity, consistency, and regulatory compliance.
Collaborate with biostatistics, regulatory affairs, medical affairs, and clinical operations teams to ensure scientific accuracy.
Conduct clinical literature searches to support medical writing projects.
Adhere to company SOPs, templates, and regulatory guidelines (including ICH-E3 and FDA) while completing assignments on time and on budget.
Monitor project budgets, ensuring work is completed within allocated hours.
Perform peer review of internal writing deliverables to maintain quality and consistency.
Minimal travel (<25%) may be 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/ICH regulations, and AMA style guidelines.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and internet research.
Familiarity with clinical research principles and drug development processes.
Excellent organizational, interpersonal, and communication skills.
Detail-oriented and capable of managing multiple projects simultaneously.
Why Join Syneos Health
Collaborate with a global, multidisciplinary team contributing to high-impact clinical trials.
Work on projects supporting FDA-approved and EMA-authorized products.
Access ongoing career development, technical training, and mentorship programs.
Be part of an inclusive culture that values diversity, creativity, and professional growth.
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 and 675,000+ trial patients worldwide.
How to Apply
Qualified candidates with the required experience are encouraged to apply today and contribute to advancing global clinical research.
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