• Prepare Clinical Study Reports (CSR) for BA/BE studies and patient-based clinical trials (PK, PD, and clinical endpoint studies) based on clinical data received after study completion, in compliance with regulatory requirements, SOPs, client standards, and approved templates
• Draft and finalize project reports with all required appendices in eCTD format, including:
– Module 2: Clinical Summary
– Module 5: Study reports, literature, appendices, and Bioanalytical Reports (BR)
• Ensure reports meet applicable regulatory guidelines and submission requirements
• Submit final compiled, signed clinical study reports (eCTD-compliant) to clients
• Coordinate with Project Managers regarding report requirements, sponsor comments, and responses
• Draft final reports and submit to sponsors through the Project Manager
• Liaise with Bioanalytical (BR) and Statistics teams to integrate bioanalytical and statistical reports into the final submission
• Address sponsor queries and incorporate feedback within agreed timelines
• Ensure documentation quality, accuracy, and regulatory compliance throughout the reporting process
• B.Pharm, M.Pharm
• Experience in clinical study report writing, BA/BE studies, or clinical research documentation preferred
• Exposure to eCTD submissions and regulatory reporting is an advantage
• Strong understanding of BA/BE and patient-based clinical trials
• Knowledge of PK, PD, and clinical endpoint studies
• Familiarity with regulatory guidelines and SOP-driven environments
• Experience with eCTD Modules 2 and 5
• Excellent medical/scientific writing skills
• Strong coordination and communication skills
• High attention to detail and compliance focus
Veeda Clinical Research (Veeda CR) is a globally reputed Contract Research Organization providing end-to-end clinical research, bioanalytical, and regulatory services. Veeda is known for its regulatory compliance, scientific excellence, and high-quality clinical documentation supporting global submissions.
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