Manager, GRA-CMC Systems Oversight
Company: Takeda Pharmaceutical
Location: Demarest
Posted on: May 13, 2022
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Job Description:
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to the best of my knowledge.
Job Description
Takeda 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 www.takedajobs.com and search for Req #
R0065024.
EEO Statement
Takeda 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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Yonkers , Manager, GRA-CMC Systems Oversight, Executive , Demarest, New York
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