Role: Scientist

Role Band: R1

Reporting To: Clinical Lead, China

Location: Beijing

Key Responsibilities:

• Draft and provide inputs for BE studies based on CFDA regulatory requirements.
• Supporting in document preparation of OHGRA, IDL, EC approval and Investigation medicinal product management and import license.
• To perform site feasibility assessment and support in CRO and hospital Site audit.
• CRO and Site identification and protocol finalization
• Identification of CRO’s for conducting the PK/BE in china.
• Coordinate with different CROs/Hospital /Bioanalytical sites to facilitate the protocol finalization process.
• Collaborate with the team for shipment of Investigational products for conducting PK/BE at CRO/Hospital Site.
• Onsite clinical monitoring for BE studies at Hospital sites.
• Follow up and get updates for the ongoing PK/BE at CRO’s.
• Collaborate and work closely with different stake holders in India and China RO office for seamless execution of Biostudies.
• Facilitate Study closeout activities at CRO/Hospital sites.
• Facilitate finalization of pivotal PK/BE -reports as per Chinese regulations and assist submission for regulatory filing.
• Assist and accompany CFDA audits to Hospital Sites.
• To provide support in addressing bio-deficiencies received from CFDA.
• Review the Clinical, Pharmacokinetic and Statistical sections of the BE reports to be submitted to regulatory agency.
• Have excellent communication skills to liaise with key functional stake holders both internally and externally towards seamless execution of the projects.

Educational Qualification & Experience:

Master of Pharmacy, Pharmacology with 4-7 Yrs of experience

主要职责：

?根据CFDA监管要求起草和提供BE研究的输入。

?支持Ohgra、IDL、EC审批和调查药品管理和进口许可证的文件编制。

?在CRO和医院现场审计中进行现场可行性评估和支持。

?CRO和现场识别和协议定稿

?确定在中国进行PK/BE的CRO。

?与不同的CRO/医院/生物分析站点协调，以促进协议最终确定过程。

?与团队合作装运试验产品，以便在CRO/医院现场进行PK/BE。

?在医院现场对BE研究进行现场临床监测。

?跟进并在CRO处获取正在进行的PK/BE的更新。

?与印度和中国反渗透办公室的不同股东密切合作，无缝执行生物研究。

?促进CRO/医院现场的研究收尾活动。

?根据中国法规，协助完成关键的PK/BE报告，并协助提交监管文件。

?协助并陪同CFDA审计到医院现场。

?为解决CFDA收到的生物缺陷提供支持。

?审查提交给监管机构的BE报告的临床、药代动力学和统计部分。

?具有良好的沟通能力，能够与关键职能利益相关者在内部和外部保持联系，实现项目的无缝执行。

学历和经验：

药学、药理学硕士，4-7年经验

上班地址：光华路东方梅地亚中心