Manager, GRA-CMC Systems Oversight

Company: Takeda Pharmaceutical
Location: Basking Ridge
Posted on: May 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda Development Center Americas, Inc. is seeking a Manager, GRA-CMC Systems Oversight in Lexington, MA with the following requirements: Bachelor's degree in a scientific major plus 3 years related experience. Prior experience must include: support in Various Regulatory Submission(s) to Health Authorities by running queries in TrackWise for post marketing support; use Quality Systems (EDMS) (Softwares includes TrackWise, VEEVA, MOSAIC, SHEDs, etc.) to track regulatory submissions and product management; follow changing guidelines by FDA (US), EMA (EU), PMDA (Japan) and various Health authorities in rest of the world for change assessment and regulatory submissions; monitor and ensure product compliance in Quality Systems (EDMS) as well as physical records as per organization guidelines.Apply on-line at and search for Req # R0065024.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Newark , Manager, GRA-CMC Systems Oversight, Executive , Basking Ridge, New Jersey