Medical Writer II – CSR Narrative Specialist (Pune)
Job Summary
Syneos Health is looking for an experienced Medical Writer II with strong expertise in CSR narrative writing and QC review. The ideal candidate will have at least 3 years of medical writing experience, including 3+ years of focused CSR narrative authoring and review. This is a high-impact role contributing to clinical documentation that supports regulatory submissions and compliance.
Join one of the world’s most trusted names in biopharmaceutical development and play a key role in advancing clinical research documentation.
Key Responsibilities
Author, edit, and review clinical documents including CSR narratives, protocols, annual reports, and investigator brochures.
Independently manage CSR narrative writing tasks with high attention to detail and compliance.
Perform peer review and QC of deliverables ensuring scientific accuracy and consistency.
Collaborate with cross-functional teams: biostatistics, data management, regulatory, and medical affairs.
Ensure adherence to ICH-E3 guidelines, FDA requirements, SOPs, and client-specific templates.
Conduct online literature reviews for medical writing support.
Stay current with evolving medical writing standards and regulatory expectations.
Track hours against budget and deliver high-quality documents within timeline constraints.
Mentor junior writers as needed and contribute to knowledge sharing within the team.
Required Skills & Qualifications
Minimum 3 years of overall medical writing experience, with 3+ years of hands-on CSR narrative writing.
Bachelor's degree in Life Sciences, Medical Sciences, Pharmacy, English, or Communications with relevant scientific knowledge.
Strong command of English grammar, AMA style, and regulatory writing standards.
Familiarity with ICH-E3, FDA guidelines, and clinical trial processes.
Proficiency in Microsoft Word, Excel, PowerPoint, and web-based tools.
Excellent written and verbal communication skills with a high degree of independence.
Perks & Benefits
Competitive compensation and performance-based bonuses (salary not disclosed)
Opportunities for global exposure and career progression
Flexible team culture with a focus on diversity and inclusion
Technical and therapeutic area training
Employee recognition and wellness programs
Company Description
Syneos Health is a global, fully integrated biopharmaceutical solutions organization working at the intersection of clinical development, medical affairs, and commercialization. With operations in over 110 countries, Syneos has supported 94% of FDA-approved novel drugs over the past 5 years, making it a trusted partner in delivering innovative therapies.
Work Mode
On-site – Pune, India
Call to Action
If you're a detail-oriented medical writing professional with a passion for CSR narratives, apply now and help shape the future of healthcare documentation.
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