Areas of expertise: Regulatory Medical Writing; Clinical & Scientific Documentation; Project Management; AI-Enabled Authoring; SOP & Template Development.
Dr. Deepti Sanghavi is a senior medical writing and clinical development professional with 15+ years of experience, including 10+ years in regulatory, scientific, and safety writing and 6+ years in global project management. She has worked closely with cross-functional stakeholders across pharmaceutical companies, CROs, biotech organizations, and AI product teams to deliver high-quality clinical documentation across Phases 2–4 and major regulatory submissions.
Deepti’s expertise spans a broad range of document types, including protocols and amendments, CSRs, IND/NDA submission components, IBs, DSURs, clinical summaries, and SOPs. She has supported more than 10 development programs for US-based companies and contributed to multiple INDs across therapeutic areas such as oncology, neurology, infectious diseases, respiratory, and cardiovascular medicine.
In her recent role as Senior Consultant Medical Writer with a US-based client, Deepti has contributed to the advancement of AI-assisted structured authoring, co-developing intelligent specifications, modular protocol templates, and context-engineered prompts for Large Language Models (LLMs). She has collaborated closely with AI/ML teams to refine protocol-authoring tools, enhance accuracy of AI-generated content, model public clinical studies, and establish SOPs, guides, and checklists that underpin digital protocol development and quality control.
Her foundation in clinical project management was built through roles at Quintiles (now IQVIA), Wockhardt, SIRO Clinpharm, and Tata Consultancy Services (TCS), where she managed complex global studies, facilitated team operations, coordinated multi-functional review cycles, and mentored writing teams. Her leadership includes serving as medical writing lead for several Roche products, overseeing end-to-end delivery of clinical documentation and ensuring adherence to global regulatory standards.
She has represented organizations as a speaker and chairperson at national and international conferences, and served on DIA advisory and organizing committees.
Deepti holds an Masters in Business Administration (MBA), a Post Graduate Diploma in Clinical Research (PGDCR), and a Bachelor of Homeopathic Medicine and Surgery (BHMS). She is also an early adopter and practitioner of AI driven writing workflows, specializing in prompt engineering, digital protocol modeling, and human-in-the-loop content refinement.