Shuo (Jason) Chen, Pharm D, R Ph
About Shuo (Jason) Chen, Pharm D, R Ph
Shuo (Jason) Chen, Pharm D, R Ph, is a Senior Manager in Oncology Global Regulatory Strategy & Policy at Bristol Myers Squibb, with extensive experience in regulatory affairs, pharmacovigilance, and oncology.
Current Role at Bristol Myers Squibb
Shuo (Jason) Chen is currently a Senior Manager in Oncology, Global Regulatory Strategy & Policy at Bristol Myers Squibb. He is based in Lawrence, New Jersey, United States. His role involves developing and implementing regulatory strategies for oncology treatments, focusing particularly on PD-1/PD-L1 and PARP inhibitors.
Previous Experience at AstraZeneca
Before joining Bristol Myers Squibb, Shuo (Jason) Chen worked at AstraZeneca in various roles. He served as a Regulatory Affairs Manager in Oncology in Gaithersburg, Maryland, from 2020 to 2021. Prior to that, he completed rotations in Global Regulatory Affairs and Global Labeling Group in 2019. Additionally, he was a Post-Doctoral Fellow in Global Patient Safety (Pharmacovigilance) in the field of Immuno-Oncology from 2018 to 2020.
Early Career and Academic Background
Shuo (Jason) Chen's career began as a Graduate Pharmacy Intern at Rite Aid Pharmacy in Flushing, New York, where he spent four years. He also worked as a Staff Pharmacist at Rite Aid Pharmacy in Atlantic City, New Jersey, from 2016 to 2018. His academic credentials include a Doctorate in Pharmacy from St. John's University, which he earned between 2010 to 2016.
Skills and Expertise in Regulatory Affairs
Shuo (Jason) Chen specializes in regulatory strategies for oncology drugs, particularly PD-1/PD-L1 and PARP inhibitors. He is experienced in handling ICH eCTD submission dossiers and IND submissions. He uses regulatory systems like Submission Management Request Tool (SMRT) and CARA Document Management Suite. His pharmacovigilance skills include ICSR handling and signal detection, using systems like Sapphire and ARGUS.
Technical Proficiency and Tools
Shuo (Jason) Chen is proficient in several programmatic tools and software. He has expertise in Microsoft Excel VBA and TIBCO Spotfire. His technical skills also extend to preparing USPI label updates and managing FDA interactions. He is adept at creating and maintaining early-phase safety profiles and adhering to Hy's Law signal detection criteria.