Vinny Negi — headshot

About

Vinny Negi

Medical Writer · PhD Biochemistry

With a PhD in Biochemistry and a decade of bench-to-bedside research, I help biopharmaceutical teams communicate science with precision and purpose — across regulatory, clinical, and commercial contexts.

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Background

I spent a decade at the bench — designing experiments, interpreting data, and publishing findings in journals ranging from Nature Communications to the Journal of Clinical Investigation. I know what it means to defend a statistical model at 3 AM before a submission deadline, and I know how to read a forest plot.

What I discovered was that the gap between rigorous science and clear communication is where clinical programs stall, where patient uptake falters, and where regulatory submissions lose credibility. I crossed that gap deliberately.

Today I work with biopharmaceutical companies, contract research organisations, and academic medical centres to translate scientific evidence into documents that do real work: abstracts that get accepted, plain language summaries that patients can act on, medical memos that align cross-functional teams, and regulatory narratives that tell a coherent clinical story.

My scientific roots are in immunology and oncology — specifically T-cell biology, checkpoint inhibition, and gene therapy delivery systems. I bring that depth to every engagement, alongside fluency in ICH guidelines, GCP, and the evolving landscape of patient-centred research.

I am a member of AMWA and EMWA, and I hold certification in medical writing from the European Medical Writers Association.

Credentials

  • PhD, Biochemistry — University College London
  • BSc (Hons), Biomedical Science — University of Manchester
  • EMWA Certified Medical Writer
  • AMWA Member
  • ICH E6(R2) GCP Certified

Education

PhD, Biochemistry

University College London

2019

BSc (Hons), Biomedical Science

University of Manchester

2014

Services

Regulatory Medical Writing

Clinical study reports (CSRs), investigator brochures, IMPDs, briefing documents, and responses to health authority queries — written to ICH E3, E6(R2), and agency-specific standards.

Scientific Publications

Original research manuscripts, review articles, case reports, and letters for peer-reviewed journals. End-to-end support from outline through submission and revisions, with full ICMJE compliance.

Congress & Conference Materials

Structured abstracts, conference posters, and oral presentation slides for ASCO, ASH, ESMO, EBMT, and other major congresses. Built for the 90-second read and the 10-minute walkthrough.

Medical Affairs Communications

Internal briefing documents, medical information letters, formulary submissions, health technology assessment (HTA) dossiers, and MSL field tools — bridging data and clinical practice.

Plain Language & Patient Communication

Plain language summaries (PLS/LPLS), patient information leaflets, clinical trial lay summaries, and disease education content — written to EUPATI, PCORI, and ICH E19 standards.

Training & Educational Content

Medical education slide decks, disease state education modules, and product theatre presentations for HCP audiences across haematology, oncology, immunology, and gene therapy.