Clinical Documentation Specialist

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‑...