Senior Medical Writer (CSR, IB, Protocol) – Syneos Health – Gurugram, India (Hybrid)
Job Summary
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Senior Medical Writer for a hybrid role based in Gurugram, India. This opportunity is ideal for experienced professionals in clinical research and regulatory writing. You'll work on Clinical Study Reports (CSR), Investigator Brochures (IB), protocols, and other key scientific documents supporting drug development and regulatory submissions.
Key Responsibilities
Lead end-to-end creation and quality review of clinical and regulatory documents
Author a variety of deliverables including protocols, CSRs, IBs, safety reports, submission documents, and patient narratives
Adhere to ICH E3 guidelines, internal SOPs, and client-specific templates
Perform quality and editorial reviews ensuring accuracy and consistency
Collaborate with clinical, statistical, regulatory, and data management teams
Review statistical outputs (SAP, TFLs) for inclusion in medical documents
Conduct literature reviews and ensure compliance with copyright standards
Mentor junior medical writers and guide complex projects
Contribute to internal process improvements and SOP updates
Ensure timely project delivery within allocated budgets
Required Skills & Qualifications
Bachelor’s or advanced degree in life sciences, pharmacy, medicine, or related field
5+ years of medical writing experience in pharma, CRO, or life sciences
Strong understanding of FDA, ICH-GCP, and regulatory requirements
Excellent command of English and familiarity with AMA Manual of Style
High proficiency in MS Office tools
Experience writing a wide range of regulatory and scientific documents
Strong grasp of clinical research principles and medical terminology
Excellent project management and peer review skills
Perks & Benefits
Competitive compensation and performance bonuses
Career advancement and global exposure
Access to therapeutic area and technical training
Inclusive, diverse work culture focused on well-being
Flexible hybrid working model (Gurugram location)
Supportive leadership and mentorship opportunities
Company Description
Syneos Health is a leading integrated biopharmaceutical solutions provider, working with 94% of novel FDA-approved drugs. With operations in over 110 countries and a workforce of 29,000+, Syneos delivers customized clinical and commercial solutions to top pharma and biotech companies.
Work Mode
Hybrid – Gurugram, India
Call-to-Action
Ready to advance your career in medical writing? Apply now to become a Senior Medical Writer at Syneos Health and contribute to global clinical development excellence.
[Apply Now]
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