Diksha Mahajan

Medical Writer with over 4 years of experience, including 3+ years of expertise in patient safety narrative writing, and 1+ year in clinical and regulatory document development, such as clinical study reports (CSRs), study protocols, Investigator’s Brochures (IBs), and CTD modules. Skilled in interpreting complex clinical and safety data to create clear, accurate, and regulatory-compliant documents for global submissions (FDA, EMA). Well-versed in ICH-GCP guidelines, CTD structure, and sponsor-specific conventions. Demonstrated strengths in quality review, cross-functional collaboration, mentoring, and delivering high-quality outputs within tight timelines.

• FDA Clinical Investigator Training Course, 2023, Completed the FDA Clinical Investigator Training Course 2023, organized by CDER SBIA, USFDA, conducted from 12/06/23 to 12/07/23, with successful participation.
• Design and Interpretation of Clinical Trials, John Hopkins University, certificate of Completion, Coursera
• Patient Safety and Quality Improvement: Developing a System view, John Hopkins University, certificate of Completion, Coursera

Master's Thesis, 2020, Implementing Molecular Docking approach to prioritize and identify novel inhibitors of SPHK-1, a Therapeutic target in Cancer, Professor Navneet Agnihotri, Head of Department, Panjab University

I, Diksha Mahajan, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.

• Reading books
• Travel
• Cooking
• Fitness and mindfulness

• English
• Hindi
• Punjabi