Report Writer

3 days ago

Rājkot, India Veeda Lifesciences Full time

Position : Report Writer

Department : Biopharmaceutics Department

Minimum Experience Required : 3-5 Years

Qualification : B.Pharm/M.Pharm/Pharm D

Key Responsibilities

- Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements.
- Analyze and interpret clinical and statistical data with a clear understanding of study results.
- subject safety narratives and ensure accurate and timely compilation of final CSR packages.
- Ensure all documents adhere to standards of grammar, formatting, structure, and consistency.
- Prepare regulatory-compliant appendices for eCTD submissions, including relevant modules.
- Collaborate closely with cross-functional teams including Data Management, Bioanalytical, Biostatistics, Regulatory Affairs, and Clinical Operations.
- Maintain effective communication.
- Apply strong working knowledge of ICH, FDA, EMA, and other relevant regulatory guidelines.
- Demonstrate excellent written communication skills.

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