AGM/DGM Clinical Trials

You will be responsible for leading the development and finalization of key clinical trial documents with a focus on scientific accuracy, regulatory compliance, and clarity. Your role will require close collaboration with cross-functional teams to support the entire lifecycle of clinical documentation, from protocol development to submission-ready deliverables. Key Responsibilities - Lead the drafting and review of clinical trial protocols in coordination with medical, regulatory, and operational teams. - Prepare high-quality clinical documents such as Clinical Study Reports (CSRs), Investigators Brochures (IBs), Informed Consent Forms (ICFs), subject-facing materials, and study training documents. - Ensure compliance with ICH-GCP, CDSCO, and internal quality standards in all clinical writing deliverables. - Assist in ethics committee and regulatory authority submissions by providing necessary documentation. - Serve as the main point of contact for cross-functional teams regarding clinical documentation. - Contribute to continuous process enhancements and standardization efforts within the clinical documentation function. Key Requirements - Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related field. - 10-18 years of experience in clinical trials, clinical documentation, or medical writing within a pharmaceutical or CRO environment. - Solid understanding of clinical research regulations and documentation requirements. - Demonstrated capability to independently draft and manage clinical trial documents. - Excellent communication, collaboration, and project management abilities. - Familiarity with global regulatory submission standards and expectations.,