aditi dey
@aditidey
PhD-qualified medical writer specializing in regulatory writing and quality control.
IndiaWhat I'm looking for
I am a PhD-qualified medical writer with over three years' experience in regulatory writing, clinical disclosures, and clinical document quality control. I specialise in reviewing and authoring CSRs, protocols, DSURs, clinical summaries, and patient narratives, ensuring scientific accuracy and regulatory compliance.
At Veranex and ICON plc I performed QC review, editing, results posting to global registries (ClinicalTrials.gov, EudraCT), redaction, and ensured adherence to client SOPs and timelines. I have authored CSR patient narratives using CIOMS, statistical tables, and CSR sources while managing multiple projects under tight deadlines.
My work is supported by strong analytical and technical proficiency, including Microsoft Office, Origin, ImageJ and STATISTICA, and I have a track record of conference presentations, publications in peer-reviewed journals, and awards such as the DST INSPIRE Fellowship and university gold medal.
I seek collaborative roles in medical communications or clinical documentation where I can apply my expertise in medical writing, QC review, clinical trial transparency, and process improvement to deliver accurate, compliant clinical documents.
Experience
Work history, roles, and key accomplishments
Medical Writing Document Reviewer
Veranex Inc.
Apr 2024 - May 2025 (1 year 1 month)
Conducted QC review and editing of clinical regulatory documents including CSRs, protocols, DSURs, and patient narratives, ensuring scientific accuracy, consistency, and regulatory compliance across submissions.
IPManaged clinical trial disclosures for global registries including protocol registrations, amendments, results posting and redaction, ensuring public-facing documentation met regulatory requirements.
IPAuthored CSR patient narratives and performed quality checks, interpreted clinical data from CIOMS, tables and listings, and supported project tracking and quality metrics to meet timelines and standards.
Education
Degrees, certifications, and relevant coursework
Vidyasagar University
Doctor of Philosophy, Physiology
2016 - 2021
Activities and societies: DST INSPIRE Fellowship; research publications and conference presentations.
Ph.D. in Physiology focused on research in physiological and biomedical topics with funded DST INSPIRE fellowship support from 2016 to 2021.
Vidyasagar University
Master of Science, Biochemistry
2012 - 2014
Activities and societies: University Gold Medallist; laboratory training (GC-MS, HPLC); conference and poster presentations.
MSc in Biochemistry completed as university topper, covering advanced biochemical techniques and research.
Vidyasagar University
Bachelor of Science (Honours), Chemistry
2009 - 2012
Activities and societies: Undergraduate research project on keratinolytic protease; participation in seminars and conferences.
Bachelor of Science (Honours) in Chemistry with coursework in chemistry and related laboratory projects.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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