In addition, you will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and external partners, to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and - You will contribute to study design, regulatory submissions, data review, and publications, while collaborating closely with cross-functional teams to maintain the highest standards of patient safety and regulatory . * You will lead the design and implementation of clinical trial protocols, ensuring adherence to ICH-GCP, ethical standards, and regulatory requirements. * You will review and analyze clinical trial data, contributing to Clinical Study Reports (CSRs), MAA/BLA submissions, and other regulatory documentation. * You will ensure regulatory compliance, providing medical guidance on safety, adverse events, and study ...
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