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Amit
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Competencias
Demonstrated experience with PubMed.
Demonstrated experience with Embase.
Demonstrated experience with Scopus.
Demonstrated experience with ScienceDirect.
Demonstrated experience with SciFinder.
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Resumen
Professional profile
Experiencia
Scientist D
Lead and mentor a multidisciplinary team of medical writers, statisticians, and content developers, producing manuscripts, abstracts, systematic reviews, plain-language summaries, and policy communications supporting national HTA and reimbursement decisions.. Design and execute systematic literature reviews and meta-analyses using PRISMA, CHEERS, and HTA-India standards to deliver publication-ready scientific and policy content.. Author and oversee technical reports, HTA dossiers, policy briefs, and peer-reviewed manuscripts for government committees and stakeholders, ensuring full regulatory and publication compliance.. Manage end-to-end project lifecycle protocol development, statistical analysis plans, and cross-functional coordination with clinicians, statisticians, epidemiologists, and compliance teams, ensuring accuracy, quality, and on-time delivery.. Develop training and capacity-building materials for national HTA initiatives; mentor team members and represent the institute at DHR, PGIMER, and ISHTA forums.. Draft precise, publication-ready abstracts from authoritative literature sources; proofread across manuscripts and final proofs, liaising with stakeholders to ensure submission-ready quality.
Research Associate
Contributed to DBT-funded translational research on smart hyaluronic acid–hydrogel systems for wound healing: study design, biomaterial characterization, and experimental execution.. Conducted SLRs, data analyses, and drafted peer-reviewed manuscripts, technical reports, and funding progress updates.
Research Scientist & Medical Writer
Led end-to-end regulatory and clinical medical writing from preclinical through Phase I–III development, ensuring compliance with ICH, GCP, and GLP standards.. Authored key regulatory documents including Investigator's Brochures, study protocols, synopses, SOPs, CRFs, Informed Consent Documents, and Clinical Study Reports (CSRs).. Managed IND/NDA submissions and maintained eCTD and Trial Master File (TMF) systems for streamlined regulatory processes.. Coordinated cross-functional clinical operations, conducted literature searches and data analyses, and presented findings to regulatory authorities.. Performed advanced proofreading and rigorous fact-checking across manuscripts, protocols, and regulatory submissions to ensure error-free, submission-ready content.. Managed tagging, linking, and referencing of cited literature per AMA style and brand/regulatory guidelines, ensuring scientific accuracy and editorial integrity.. Conducted medical and language editing across protocols, CSRs, and literature summaries, upholding strict editorial, quality, and regulatory compliance.
Post-Doctoral Fellow
Led NIH-supported research on oxidative stress, mitochondrial dysfunction, and aldehyde metabolism in cardiovascular diseases; published findings in peer-reviewed journals.
Senior / Junior Research Fellow (PhD)
Completed PhD on novel bionanomaterials for drug delivery; published in high-impact journals (Biotechnology Advances IF 17.6, Journal of Colloid and Interface Science IF 9.9).. Presented at the Indian Science Congress and the International Nanotek & Expo (Las Vegas, USA); received an International Travel Grant from DST, DBT, ICMR & CSIR.