Medical Writer II (Narrative Writing) – Gurgaon, India
Job Summary:
Syneos Health is seeking an experienced Medical Writer II (Narrative Writing) to join its growing clinical and medical writing team in Gurgaon. This role focuses on CSR safety narratives, clinical study reports, and regulatory documents, ensuring adherence to ICH E3 guidelines, FDA regulations, and client-specific templates. The position is ideal for professionals with a strong background in medical writing within the biopharmaceutical or CRO industry, passionate about translating clinical data into clear, accurate, and regulatory-compliant content.
Key Responsibilities:
Author, edit, and finalize CSR safety narratives, clinical study reports, and related documents.
Collaborate with cross-functional teams to address review comments and ensure document consistency.
Prepare documents such as clinical study protocols, annual reports, investigator brochures, and patient narratives.
Perform peer reviews to ensure quality, scientific accuracy, and adherence to style guidelines.
Review statistical analysis plans and provide input on tables, figures, and listings.
Conduct literature reviews and ensure compliance with copyright requirements.
Mentor junior medical writers and provide guidance on best practices.
Manage document reviews, resolve client feedback, and deliver content within budgeted timelines.
Required Skills & Qualifications:
Bachelor’s degree in life sciences or a related field; advanced degree preferred.
Minimum 2 years of medical writing experience, preferably in CSR narratives and regulatory documents.
Familiarity with FDA, ICH E3, and regulatory guidelines.
Proficiency in English grammar, with strong communication and editing skills.
Experience with AMA Manual of Style and industry-standard templates.
Prior experience in CRO, biopharmaceutical, or medical device industry is a plus.
Perks & Benefits:
Competitive salary and performance-based rewards.
Comprehensive health and life insurance plans.
Opportunities for career growth and continuous learning.
Flexible work environment and supportive team culture.
Global exposure to leading pharmaceutical and biopharma projects.
Company Description:
Syneos Health is a global biopharmaceutical solutions organization with over 29,000 employees across 110 countries. Known for accelerating clinical development, Syneos Health partners with top pharma and biotech companies to deliver impactful therapies worldwide.
Work Mode: On-site (Gurgaon, India)
Call-to-Action:
If you are a skilled medical writer with experience in CSR narratives and regulatory submissions, apply now to join Syneos Health and contribute to meaningful projects that improve patient outcomes.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Canada |Quebec :
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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