应届毕业生
本科
最近更新
953人关注
职位描述
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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
● 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
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工作地点
地址：上海静安区南京西路中信泰富广场
求职提示：用人单位发布虚假招聘信息，或以任何名义向求职者收取财物（如体检费、置装费、押金、服装费、培训费、身份证、毕业证等），均涉嫌违法，请求职者务必提高警惕。
职位发布者
辉瑞HR..HR
辉瑞制药有限公司
-
制药·生物工程
-
1000人以上
-
外商独资·外企办事处
-
碑林区和平路116号金鼎大厦303
