應屆畢業生
本科
最近更新
958人關注
職位描述
該職位還未進行加V認證，請仔細了解后再進行投遞！
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
注：聯系我時，請說是在蘿崗人才網上看到的。
工作地點
地址：上海靜安區南京西路中信泰富廣場
求職提示：用人單位發布虛假招聘信息，或以任何名義向求職者收取財物（如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業證等），均涉嫌違法，請求職者務必提高警惕。
職位發布者
輝瑞HR..HR
輝瑞制藥有限公司
-
制藥·生物工程
-
1000人以上
-
外商獨資·外企辦事處
-
碑林區和平路116號金鼎大廈303
