Clinical Study Report (CSR) Writer

Min Exp - 7-9 yearsLocation - GurgaonEducation - Master’s in Pharmacy, Medicine, or related field.About the RoleWe 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 ResponsibilitiesAuthor, 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 & SkillsMaster’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 SkillsKnowledge 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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