Senior Medical Writer (CSR, IB, Protocol) – Remote India | Syneos Health
Job Summary
Syneos Health is seeking an experienced Senior Medical Writer to lead regulatory and scientific document creation including Clinical Study Reports (CSR), Investigator Brochures (IB), and protocols. This remote role in India is ideal for professionals with 5+ years of medical writing experience in the pharmaceutical or CRO industry. The position involves independent project leadership, regulatory compliance, cross-functional collaboration, and mentoring.
Key Responsibilities
Write and manage clinical study documents: protocols, CSRs, IBs, patient narratives, IND/NDA submissions, etc.
Adhere to ICH E3, company SOPs, and client templates and standards
Coordinate internal reviews and ensure high-quality, scientifically accurate content
Serve as subject matter expert and peer reviewer for complex regulatory deliverables
Interpret clinical data, perform literature reviews, and ensure copyright compliance
Collaborate with cross-functional teams in clinical, regulatory, biostatistics, and data management
Review and refine statistical outputs and ensure document consistency
Lead medical writing efforts across studies and manage multiple deliverables
Mentor junior writers and contribute to knowledge sharing
Required Skills & Qualifications
Bachelor’s degree in life sciences or medical-related field; graduate degree preferred
Minimum 5 years of relevant experience in medical or scientific writing
Strong knowledge of ICH-GCP, FDA regulations, and regulatory document standards
Experience with submissions to global regulatory agencies (e.g., IND, NDA, eCTD)
Proficiency in Microsoft Office and AMA Manual of Style
Strong command of medical terminology and ability to synthesize clinical data
Excellent attention to detail, time management, and communication skills
Prior experience in a CRO or biopharma setting highly desirable
Perks & Benefits
Fully remote role with flexible work hours
Competitive salary and performance-based incentives
Opportunities for global project exposure
Career development programs and mentorship
Diverse, inclusive, and collaborative company culture
Employee recognition and rewards programs
Company Description
Syneos Health is a leading global provider of fully integrated biopharmaceutical solutions. Working across 110+ countries, Syneos has contributed to 94% of all novel FDA approvals in the past five years. With a strong focus on clinical development, commercial insights, and patient engagement, the company is committed to accelerating drug delivery and transforming global healthcare.
Work Mode
Remote – India
Call-to-Action
Ready to make a global impact in medical writing? Join Syneos Health as a Senior Medical Writer and help shape the future of clinical research.
Apply now and advance your career in regulatory writing.
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