Key Responsibilities :
- Review and assess medical documents, including clinical trial data, safety reports, and regulatory submissions, for accuracy, consistency, and compliance with industry standards.
- Assist in the preparation of regulatory documents, such as clinical study reports, informed consent forms, and patient safety reports.
- Ensure that all content aligns with medical and scientific guidelines, including Good Clinical Practice (GCP) and regulatory requirements.
- Collaborate with senior medical reviewers and other cross-functional teams (e.g., clinical research, pharma co-vigilance, regulatory affairs) to ensure the timely and accurate delivery of medical documents.
- Review medical literature and stay updated on the latest clinical and scientific research relevant to assigned projects.
- Identify and flag potential issues or discrepancies in clinical trial data or reports.
- Assist in the preparation of training materials or presentations related to medical review processes.
- Support senior medical reviewers in maintaining high standards of medical and scientific integrity.
Skills Required
Medical Coding, Medical Writing, Clinical Research, Clinical Data Management, Medical Summarization