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Job Description & How to Apply Below
Min Exp - 7-9 years
Location - Gurgaon
Education - Master’s in Pharmacy, Medicine, or related field.
About the Role
We are seeking an experienced Clinical Study Report (CSR) Writer to develop high‑quality clinical documentation for regulatory submissions. The ideal candidate has hands‑on experience with ICH‑E3 compliant CSRs and can work seamlessly with multidisciplinary teams.
Key Responsibilities
Author, review, and finalize Clinical Study Reports (CSRs) for Phase I–IV studies.
Ensure compliance with ICH‑E3 , protocol, and regulatory standards.
Interpret and present clinical data, TFLs, and statistical outputs clearly and accurately.
Collaborate with clinical, statistical, regulatory, and medical teams.
Manage timelines and deliverables in a fast‑paced environment.
Maintain accuracy, consistency, and scientific clarity across documents.
Required Qualifications & Skills
Master’s in Pharmacy, Medicine , or related field.
7-9 years of experience in medical writing with a strong focus on CSRs.
Solid understanding of GCP , ICH guidelines, and regulatory documentation practices.
Excellent communication and attention to detail.
Good to have Skills
Knowledge of AI‑assisted writing tools, data review tools, or familiarity with how AI can support medical writing workflows (e.g., document QC, data summarization, or automation).
Ability to adapt to tech‑enabled writing environments.
Interested candidates please share the resume at
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