Senior Specialist, HGR Management
Typical Accountabilities
- To internally lead communication and alignment with functions of R&D. China, Science Units and other. relevant China/global functions on related HGR topics.
- To externally keep active communication with authority and industry, contributing industry infrastructure development.
- To set-up one-stop communication platform to exchange and promote general information related to HGR locally and globally.
- To lead development and update of SOP, working process, supporting tools and reference.
- To optimize internal training and knowledge sharing system, ensure timely information and experience sharing within cross team.
- To ensure regular refreshing training is conducted and training records related to are well kept.
- To lead oversight of HGR activities for both internal and outsourced study and as well as sample and data handling vendors.
- To lead full cycle of HGR related sample and data management.
- To lead HGR inspection and internal auditing readiness and oversee assigned activities to be completed.
- To lead development of HGR information management system and endure it could support oversight and inspection readiness.
Education, Qualifications, Skills and Experience
Essential
- Master or above in medical, pharmaceutical, and biological science
- Above 5-year industry experience of clinical trial
- Above 2-year HGR working experience
- Strong leadership in interacting with multiple internal and external stakeholders and team management
- Excellent communication and facilitation skills
- Excellent skill in critical thinking and problem solving
- Extensive enterprise knowledge in multi-national company with demonstrated influencing skills to remove obstacles and facilitate cross-functional delivery
Desirable
-Knowledge and understanding of China HGR regulation
【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
