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Responsibilities

● Act as a point-of-contact (POC) and subject matter expert (SME) for
clinical quality requirements and activities in China for assigned portfolios,
studies, or vendors.
● Implement strategies and activities related to inspection readiness and
audit response management for clinical development conducted in China.
● Lead the development of Risk/Quality Plans for Development China
functions and the China clinical trial portfolio and associated key vendors
when needed.
● Support GCP quality event reporting, assessment, investigation, and
remediation activities for GCP quality issues related to China clinical
development activities.
● Develop and deliver GCP quality relevant training as needed



Minimal/Must-have Requirement

● A scientific or technical degree; an advanced degree (MS/MD/PhD) is
preferred.
● Extensive clinical development and business experience that demonstrates
a thorough understanding of the processes associated with clinical and
regulatory operations.
● Knowledge of local and international regulatory requirements, especially
intensive experience in CFDI/FDA Inspection.
● At least 5 years of increasingly responsible positions in Clinical
Operation and/or Clinical Development Quality.



#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.




Quality Assurance and Control