Sheetal Rathod

Detail-oriented and dedicated Medical Writer with over 5 years of experience in clinical research and regulatory documentation. Expertise in drafting and reviewing clinical study reports, protocols, informed consent form, patient narratives, and manuscripts. Demonstrated understanding of ICH-GCP guidelines, documentation, and regulatory requirements.

Medical Writer at Meril Life Sciences Pvt Ltd (2021-01 – Present)

• Lead writing and critical review of clinical study reports (CSRs) (including first-in-man), phase III and IV studies in compliance with ICH E3/E6, apply CONSORT/SPIRIT standards, Post market clinical follow-up (PMCF) Plans/reports, prepare patient safety narratives, and ensure accuracy through review of SAPs, tables, figure and listings.
• Independently manage multiple studies including clinical data interpretation, protocol development/amendments, and development/review of CRFs, IBs, Critical investigation plan CIPs/protocol (MDCG 2024-3), and ICDs, ensuring regulatory and quality alignment.
• Collaborate cross-functionally (data management, biostatistics, regulatory, medical affairs), conduct literature reviews, and manage refrencing using EndNote, and support manuscripts, peer reviews, and preclinical reports for effective scientific communication.
• Contribute to regulatory documentation (STED, CER, gap analysis), dossier preparation/submissions, response documents, and compendium presentations on healthcare/cardiac devices.
• Prepare and review preclinical study manuscripts, scientific reports, and experimental research documents in compliance with scientific and regulatory standards.
• Ensure ethical, plagiarism-free, and confidential writing, deliver training to junior writers, support document lifecycle/formatting, utilize MS Office for reporting/presentations, and handle additional responsibilities as assigned.

Intern – Bioanalytical Research at Veeda Clinical Research Pvt. Ltd (2018-08 – 2019-02)

• (M. Pharma) Project Title: Bioanalytical Method Development and Validation for Estimation of Nintedanib in K3EDTA Human Plasma using LC-MS/MS.

Master of Pharmacy in Quality Assurance – Smt. B.N.B. Swaminarayan Pharmacy College, Salvav, Vapi – GTU (2019-05)