Arpit Shah
Clinical Development I Medical Writing I Regulatory Intelligence I Medical Affairs I Biosimilars Clinical Development I RWE | HEOR
- Role
- Director & Head, Medical Writing Operations at Worldwide Clinical Trials
- Location
- Kochi, KL, IN
- LinkedIn followers
- 500 followers
About Arpit Shah
Experienced professional specializing in Clinical Development, Medical Writing, Medical Affairs, and Medical Information & Regulatory Intelligence. Committed to fostering innovation and excellence within the medical industry. Passionate about driving innovation and excellence in the Clinical Drug Development field Experienced Leader in Regulatory and Scientific Writing | With a wealth of experience in all phases of Clinical Research and Real-World Evidence (RWE) Studies, I contribute to the generation of valuable insights and evidence-based strategies. Driving Excellence in Regulatory Medical Writing and Scientific Writing With a focus on driving excellence in Regulatory Medical Writing and Scientific Writing, I take pride in leading a team of talented regulatory and scientific writers. Possessing a keen eye for detail and a profound understanding of industry guidelines, I ensure that our work consistently meets the highest standards of quality and compliance.Passionate about staying at the forefront of AI trends in medical writing. Leveraging AI-enabled technology, I strive to achieve accelerated submission processes and enhanced efficiency in our operations. Meticulous and Detail-Oriented Approach to Regulatory Writing My dedication to precision and accuracy is reflected in my work. I meticulously navigate the complex regulatory landscape, ensuring that all documents adhere to strict guidelines and regulations. By effectively communicating complex scientific information, I help drive the success of clinical trials and product approvals. Expertise in Clinical Research (and RWE Studies) Accumulated comprehensive expertise across all phases of clinical research, spanning from Phase 1 through Phase 4. My active involvement in RWE studies has allowed me to contribute to the development of valuable insights and evidence-based strategies.#regulatoryMedicalWriting #ClinicalDevelopment
Experience
Director & Head, Medical Writing Operations
Feb 2026 — Present · IN
Led the Regulatory Medical Writing Operations team, ensuring high-quality scientific documentation. • As, subject matter expert, providing guidance on regulatory writing standards and best practices. • Managed stakeholder relationships to facilitate effective communication and project alignment. • Developed strategic decisions to ensure business continuity and enhance operational efficiency.• Lead regulatory medical writing, safety writing, and RWE & HEOR projects to accelerate drug development for pharma and biopharmaceutical companies.• Providing FSP Model to optimize submission processes for Drug approval, ensuring fit-to-size services for clients.
Education
Nitte University
Masters in Pharmacy, Pharmacology
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy, Pharmacy
NGSM Institute of Pharmaceutical Sciences
Diploma in Pharmacy , Pharmacy
Government of Karnataka Project
Bachelor of Pharmacy
Monad University
Doctor of Philosophy - PhD, Pharmacology and Toxicology
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