• Review and provide comments on draft clinical protocols, Informed Consent Documents (English ICD), Case Report Forms (CRF), and related documents as per SOPs and applicable regulatory guidelines
• Review and comment on draft clinical reports, including clinic-related sections and appendices, in compliance with SOPs, regulatory guidelines, and sponsor requirements
• Review final eCTD reports received from report writers to ensure regulatory and submission readiness
• Ensure document reviews are completed within defined timelines and priority requirements
• Review updated documents incorporating sponsor comments and regulatory observations to ensure compliance
• Review sponsor comments and regulatory queries and provide appropriate responses within stipulated timelines
• Participate in the review and maintenance of departmental SOPs
• Coordinate with internal teams for implementation of new or revised SOPs
• Ensure corrective and preventive actions (CAPA) are implemented for identified findings, comments, or gaps
• Perform any additional responsibilities assigned by the reporting authority
• B.Pharm (Any Specialization)
• M.Pharm / MS / M.Sc (Science – Any Specialization)
• Experience in clinical research documentation, regulatory review, or clinical operations is preferred
• Exposure to SOP-driven environments and regulatory guidelines is an advantage
• Strong knowledge of clinical research documentation and regulatory requirements
• Attention to detail and compliance-focused mindset
• Ability to manage timelines and work on priority-based tasks
• Good written communication and document review skills
• Ability to coordinate with cross-functional teams
• Understanding of SOPs, eCTD structure, and sponsor/regulatory interactions
Veeda Clinical Research (Veeda CR) is a globally recognized clinical research organization providing integrated solutions across clinical development, bioanalytical services, and regulatory support. Veeda is known for its strong compliance culture, scientific expertise, and commitment to delivering high-quality, regulatory-compliant clinical research services.
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