北京招聘

Purpose

?      Support China on HGRAC management by serving as HGRAC internal expertise, providing oversight on HGRAC applications, and participating on continuous enhancement of HGRAC-related processes.

 

Responsibilities, Key Activities and Deliverables

?      Serve as business process owner (BPO) for HGRAC Management Process (from initial application compilation through to study closure).

?      As HGRAC BPO, be responsible to develop and maintain HGRAC SOPs/Work Instructions working closely with QCA (Quality, Compliance & Audit) team and identified BPOs.

?      Lead/project manage and /or participate to provide input on relevant tasks force teams related to HGRAC activities, as assigned by line manager.

?      Be responsible for interpretation of HGRAC regulations and implementation guidelines following consultation with HGRAC officers.

?      Set up and monitor key performance metrics on HGRAC-related activities and HGRAC compliance

?      Develop CAPAs to address any performance and compliance gaps identified,  in collaboration with QCA function

?      Develop and deliver training on an ongoing basis to key stakeholders involved in the HGRAC process.

?      Serve as China SME for all HGRAC-related activities, working with various local and global cross-functional stakeholders and respective study team leads to ensure the HGRAC applications are conducted in a timely and compliant manner.

?       Perform internal review of HGRAC applications prior to submission.

?      Provide oversight on HGRAC submissions across China study portfolio, lead timely communication of status and issues effectively to HGRAC governance team.

?      Perform internal review of HGRAC annual self-check report prior to submission.

?      Provide SME input for HGRAC-related inspections

?      Coordinate HGRAC quality improvement initiatives in collaboration with QCA function

?      Develop and build relationships with HGRAC officers, serve as  primary POC with HGRAC.

?      Participate on appropriate professional and continuing education trainings externally available and internally organized at Covance to continuously build knowledge and expertise on HGRAC-related requirements.

Key Competencies

?      Effective leadership skills

?      Ability to work in cross-functional teams  and exhibit strong collaboration skills

?      Ability to manage team(s) to accomplish increasingly complex, specific projects.

?      Ability to influence and motivate others outside of direct line of authority.

?      Ability to interface effectively with all levels.

?      Ability to navigate through a complex team or matrix environment.

?      Effective meeting management.

?      Quick learner, proactive, takes initiative.

?      Skilled in understanding highly ambiguous situations.

?      Results oriented and goal driven.

?      Strong oral and written communication skills.

?      Ability to organize, interpret communicate and present information effectively.

?      Strong problem-solving skills.

?      Able to develop creative output based on interpretation and analysis.

?      Excellent organization and planning skills with an attention to detail.

?      Ability to work independently.

?      Demonstrates willingness to put an extra effort when necessary to pursue tasks to conclusion.

 

Preferred Qualifications

?      BA/BS/BSc in life science or relevant

?      Minimum 8 years of  experience within Pharmaceutical/CRO industry, with  prior clinical operations /drug development experience; minimum  2 years of HGRAC submissions experience

?      Excellent written and oral communication skills in both English and Mandarin

• Advanced knowledge of clinical trials management including regulations, guidelines, and clinical trial processes

Knowledge (China-Specific)

?      HGRAC Regulations

?      Extensive knowledge of ICH/GCP regulations and guidelines.

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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