Nisha Kamath

I've translated complex scientific data into manuscripts, technical documentation, and presentations for healthcare, academic, and biopharma audiences. I'm transitioning into regulatory medical writing focused on therapeutics.

At Case Western Reserve University, I authored two first-author manuscripts and published findings on approximately 700 missense protein variants that support clinical variant-classification decisions in patient care. I also built a semi-automated next-generation sequencing variant-calling pipeline using Python and R.

At Thermo Fisher Scientific's BioProduction Division, I drafted applications data for white papers and protocols supporting CTS OpTmizer Pro, documented product development under cGMP guidelines, and partnered with Operations and Regulatory Affairs on biologics-manufacturing requirements.

I'm AMWA-certified in Regulatory Core Knowledge and bring knowledge of ICH guidelines, FDA 21 CFR, GCP, cGMP, and clinical and regulatory documents including CSRs, ICFs, INDs, and NDAs. I enjoy making rigorous science understandable for diverse audiences.