Shwetha R.
About Shwetha R.
Shwetha R. is a Senior Medical Writer specializing in regulatory writing, currently employed at Fortrea. With extensive experience in the pharmaceutical and biotech industries, she has authored key regulatory documents and managed complex narrative projects.
Current Role at Mirati Therapeutics
Shwetha R. serves as a Senior Medical Writer (Regulatory) at Mirati Therapeutics, where she has been employed since 2022. In this role, she is responsible for authoring and managing regulatory writing assets, including Investigator's Brochures (IBs) and Development Safety Update Reports (DSURs). Her work involves ensuring precision and adherence to industry standards in the development of complex regulatory documents. Shwetha operates in a remote capacity, contributing to the company's regulatory writing efforts from the United States.
Previous Experience in Medical Writing
Before joining Mirati Therapeutics, Shwetha R. held various positions in medical writing across multiple organizations. She worked as a Principal Medical Writer at Vedics from 2022 to 2023 and as a Medical Writer IV at AbbVie from 2021 to 2022. Additionally, she served as a Senior Medical Writer at Scigen for five years, from 2016 to 2021. Her experience also includes a role at Merz Pharma GmbH & Co KGaA, where she worked from 2014 to 2017, and as a Medical Writer at Malibu Health Labs from 2010 to 2011.
Educational Background and Qualifications
Shwetha R. has a strong educational foundation in health sciences. She studied at Rajiv Gandhi University of Health Sciences and later pursued a Master's degree in Pharmacology at the University of Hertfordshire from 2009 to 2010. This academic background supports her expertise in medical writing and regulatory documentation within the pharmaceutical and biotech industries.
Consultation and Project Management Skills
In her roles, Shwetha R. has consulted with programmers to develop outputs for various narrative writing projects. She has experience in managing and coordinating complex narrative projects within the pharmaceutical, biotech, and contract research organization (CRO) sectors. Her responsibilities include reviewing Statistical Analysis Plans (SAP) and ensuring appropriate data presentation for Clinical Study Reports (CSRs), highlighting her attention to detail and commitment to quality in regulatory writing.
Internship and Early Career Experience
Shwetha R. began her career with an internship as a doctor at the Government of India from 2007 to 2008 in Bangalore. This early experience in a clinical setting provided her with foundational knowledge in healthcare, which she later applied in her medical writing career. Her diverse background has contributed to her understanding of the regulatory landscape and the complexities involved in medical documentation.