Preethi G.

• Building pipelines using Python and R to process large volumes of genomic data (6 million data points for each of 3,000+ individuals) in order to develop polygenic risk score distributions for 20+ populations worldwide. • Experimentally creating predictive models of populations by building statistical simulations in order to better understand the evolutionary basis of disease risk distribution.

• Interfaced with clients and internal contacts in multiple departments in order to ensure smooth and fast-paced production of high-quality deliverables within tight timelines (usually less than 48 hours). • Acted as a primary client point of contact and managed US submissions for 13 Investigational New Drugs. • Worked in a cross-functional team tasked with the planning/implementation of a new electronic system of submission management in change management and regulatory consulting function. • Analyzed, visualized, and presented internal operations data for 70+ countries in order to determine optimal strategy for system rollout with minimal disruption. • Coordinated global regulatory submissions for studies with up to 15 countries.

• Aggregated and verified the quality of 10,000+ points of stability data used to author a New Drug Application. Identified discrepancies and inaccurate data, leading to the reissue of stability reports prior to FDA review. • Maintained audit-ready document archives in both a physical location and an electronic content management system. • Acted as a cross-functional liaison to ensure seamless documentation of all study related information and submissions. Created, updated, and maintained study specific information in internal document management and tracking systems in accordance with relevant SOPs. • Compiled and managed electronic and paper regulatory submissions to US, Canadian, and global regulatory authorities. • Registered and maintained clinicaltrials.gov records for multiple studies. • Created and interpreted CMC data for inclusion in an NDA. • Assisted with project budgeting, forecasting, and bidding in SalesForce. • Assisted with departmental administrative tasks such as training coordination, and ad-hoc project support.

• Researched the effects of endogenous neuromodulators by running neurochemical experiments start to finish using carbon fiber microelectrodes in rat models (behavioral and anesthetized). • Fabricated carbon fiber microelectrodes for use in experiments. • Wrote a paper and presented a poster detailing this research. • 2013 ACS Undergraduate Analytical Chemistry Award recipient

• Corresponded with 20+ liaisons to review and ensure relevancy of internally published country intelligence. • Transitioned intelligence content for 50+ countries into a newly implemented internal database. • Published updated information through through portals internal access via the internet.