Rituparna Naath
@rituparnanaath
Experienced medical writer specializing in clinical trial documentation, regulatory submissions, and AI-assisted writing.
IndiaWhat I'm looking for
I am a clinical research and medical writing professional with over eight years' experience delivering regulatory documentation, informed consent forms, lay summaries and safety narratives across drug and device studies globally. I specialize in regulatory submissions for APAC, EMEA and US regions and apply AI tools to improve document quality and speed.
At Thermo Fisher I led ICF template development, served as a senior reviewer and managed end-to-end project execution to support timely regulatory filings. I bring strong project management, regulatory intelligence and mentoring experience and seek roles where I can lead complex writing projects and improve patient-centric communications.
Experience
Work history, roles, and key accomplishments
TSMedical Writer
Thermo Fisher Scientific
Jun 2022 - Present (3 years 2 months)
Spearheaded development of informed consent forms, lay summaries, and safety narratives using AI tools, improving document quality and accelerating regulatory submission timelines. Managed end-to-end project execution, stakeholder engagement, and served as senior reviewer for deliverables.
WLConducted literature reviews, meta-analyses, and regulatory surveillance to support device promotional materials and PMS reports across EMEA, LATAM, and APAC. Mentored junior writers and performed quality control for regulatory submissions and vigilance reports.
CSDrafted CSR narratives and processed CIOMS/CRF data while managing clinical data cleaning and SOP-compliant database activities. Supported client discussions and resolved data inconsistencies to ensure regulatory-quality deliverables.
Research Analyst
Prasanta Banerjee Homoeopathy Research Foundation
Jan 2017 - Jun 2017 (5 months)
Coordinated clinical studies, consent processes, and site communications while maintaining training documentation and study initiation records. Assisted the principal investigator in timely submission of closeout documents and provided study team training.
Education
Degrees, certifications, and relevant coursework
JUJadavpur University
Postgraduate Diploma, Clinical Research & Regulatory Affairs
Postgraduate Diploma in Clinical Research & Regulatory Affairs from Jadavpur University, completed in 2012.
WTWest Bengal University of Technology
Master of Science, Genetic Engineering
Master of Science in Genetic Engineering from West Bengal University of Technology, completed in 2010.
UCUniversity of Calcutta
Bachelor of Science, Microbiology
Bachelor of Science in Microbiology from the University of Calcutta, completed in 2008.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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