Report Writer

4 weeks ago

Ahmedabad, 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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