Scientific Medical Writer, Medical Affairs
Indegene
Bengaluru, India (Remote)
10.2021 - 06.2024
- Authored, reviewed, and enhanced clinical trial protocols, medical responses, and scientific content for pharmaceutical clients, including Novartis, Takeda, and Incyte, focusing on CNS, oncology, and rare diseases.
- Reviewed clinical data and adverse event documentation to ensure accuracy and regulatory compliance supporting Expanded Access Programs.
- Collaborated with clinical managers, investigators, pharmacovigilance, and regulatory teams to ensure data integrity and adherence to GCP guidelines.
- Led clinical project operational activities, including site selection, feasibility assessments, and protocol training for multi-regional trial sites.
- Conducted literature reviews, data analysis, and prepared reports aiding Data Safety Monitoring Boards and medical monitoring functions.
- Provided expert feedback for protocol deviation management, ensuring ethical conduct and clinical rigor.
- Collaborated with cross-functional teams to streamline content development processes and enhance document clarity.