Report Writer - Biopharmaceuitics and Project Management

Position

Department

Minimum Experience Required

Qualification

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.