Job Title:
Senior Medical Writer (Authoring CSR Narratives)
Company:
Syneos Health
A global biopharmaceutical solutions company operating in 110 countries, delivering clinical development, medical affairs, and commercialization services.
Location:
Gurugram, India (Hybrid, Asia-Pacific region)
Job ID:
25002558-IND002
Updated:
April 28, 2025
Job Summary:
As a Senior Medical Writer, you will lead the creation of a variety of clinical and regulatory documents including Clinical Study Reports (CSR), narratives, protocols, and submissions. This role includes mentoring junior writers and managing document development across cross-functional teams.
Key Responsibilities:
Serve as lead writer on complex clinical documents including CSR narratives, protocols, and submissions.
Mentor and guide junior or less experienced writers.
Write, review, and coordinate key documents such as:
Clinical study reports and patient narratives
Protocols/amendments
Investigator brochures
INDs, NDAs, (e)CTDs
Clinical manuscripts and presentations
Review SAPs and TFL specifications for clarity and accuracy.
Ensure documents meet ICH-E3, FDA guidelines, AMA style, and company/Sponsor templates.
Participate in internal and cross-functional reviews.
Maintain document quality and compliance within budget and timelines.
Conduct literature searches and stay updated on regulatory and industry changes.
Qualifications:
Required:
Bachelor of Science or Bachelor of Arts (in English, Social Sciences, or Communications) with strong scientific/medical understanding.
Strong command of English grammar and familiarity with AMA style.
Proficiency in Microsoft Word, Excel, PowerPoint, and literature databases.
High degree of independence, leadership, and cross-functional collaboration.
Working knowledge of clinical trial processes and ability to interpret data.
Preferred Skills:
Experience writing CSR narratives.
Knowledge of regulatory submission processes (IND, NDA, CTD).
Exposure to a variety of therapeutic areas and document types.
Prior work in a CRO or pharma environment.
About Syneos Health:
A leader in biopharma services, Syneos Health supports over 94% of FDA novel drug approvals and 95% of EMA-authorized products. The company emphasizes career development, diversity, and a “Total Self” culture that values inclusion and authenticity.
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