James Levanduski
About James Levanduski
James Levanduski is a Senior Scientific Writer in Global Scientific and Regulatory Documentation at Bristol-Myers Squibb, with a background in pharmacy and regulatory affairs.
Title
James Levanduski holds the position of Senior Scientific Writer in Global Scientific and Regulatory Documentation at Bristol-Myers Squibb.
Company
James Levanduski is currently employed at Bristol-Myers Squibb, where he takes on responsibilities as a Senior Scientific Writer in the Global Scientific and Regulatory Documentation department.
Education and Expertise
James Levanduski earned his Doctor of Pharmacy (PharmD) degree from the University of Rhode Island, completing his studies between 2010 and 2016. His academic background equips him with comprehensive knowledge in pharmacy and brings significant expertise to his current role.
Professional Background
James Levanduski has accumulated diverse experience through various roles. His roles include being a Pharmacist at CVS Pharmacy from 2014 to 2016 in Lancaster, Pennsylvania, and having intern experience with the FDA's Office of Generic Drugs in Washington D.C in 2016. He also held internships at Memorial Hospital of RI, Cardinal Health, Anchor Medical Group, Magellan Health, and Target.
Current Role and Responsibilities
In his role at Bristol-Myers Squibb, James coordinates and authors various regulatory documents including Clinical Study Reports, Summary Documents, Briefing Books, Periodic Safety Reports, Risk Management Plans, and Health Authority Responses. He ensures the integration of scientific, medical, and regulatory input from cross-functional teams for regulatory submissions, leads meetings and strategy sessions, manages timelines and planning, and reviews and edits documents for accuracy and compliance. Additionally, he effectively oversees multiple document projects simultaneously.