職位描述
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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
工作地點(diǎn)
地址:上海靜安區(qū)南京西路中信泰富廣場(chǎng)
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詳細(xì)位置,可以參考上方地址信息
求職提示:用人單位發(fā)布虛假招聘信息,或以任何名義向求職者收取財(cái)物(如體檢費(fèi)、置裝費(fèi)、押金、服裝費(fèi)、培訓(xùn)費(fèi)、身份證、畢業(yè)證等),均涉嫌違法,請(qǐng)求職者務(wù)必提高警惕。
職位發(fā)布者
輝瑞HR..HR
輝瑞制藥有限公司
-
制藥·生物工程
-
1000人以上
-
外商獨(dú)資·外企辦事處
-
碑林區(qū)和平路116號(hào)金鼎大廈303
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2026-01-09 06:08:00
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注:聯(lián)系我時(shí),請(qǐng)說(shuō)是在河北人才網(wǎng)上看到的。
