Clinical Study Report (CSR) Writer

Min Exp - 7-9 years

Location - Gurgaon

Education - Masters in Pharmacy, Medicine, or related field.

About the Role

We are seeking an experienced Clinical Study Report (CSR) Writer to develop highquality clinical documentation for regulatory submissions. The ideal candidate has handson experience with ICHE3 compliant CSRs and can work seamlessly with multidisciplinary teams.

Key Responsibilities

• Author, review, and finalize Clinical Study Reports (CSRs) for Phase IIV studies.
• Ensure compliance with ICHE3, 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 fastpaced environment.
• Maintain accuracy, consistency, and scientific clarity across documents.

Required Qualifications & Skills

• Masters 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 AIassisted 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 techenabled writing environments.

Interested candidates please share the resume at shalini.kanwar@wns.com