Senior Specialist, HGR Management
The Senior Specialist, HGR Management work closely with Local Study Team to ensure the quality HGR application submission. He/She is responsible for facilitating the related activities to Development Operations in HGR application submission, HGR process management and excellence, compliance oversight and inspection readiness and system issue solution.
Typical Accountabilities
- Facilitate HGR application submission, including but not limited to draft the application form, on-line submission, site filing, tracking and application form format review based on study need in a timely manner.
- Implement HGR strategy at study level to keep low rejection rate and good compliance in line with the regulation and internal process.
- Oversee HGR compliance during study execution, including but not limited in HGR submission application, HGR quality issue & CAPA review, China HGR sample and data lifecycle management, study remaining sample retention.
- Facilitate the HGR inspections on study level and country level, including but not limit to sample management and data re-use.
- Responsible for authority contact and consultation, conduct the HGR regular refreshing training and ensure the training records are well kept.
- Support the development and upgrade the internal used HGR system.
- Support to the development and update of working process, supporting tools and reference.
- Coordinate the resolution of HGR non-compliance issue to ensure AstraZeneca with HGR regulation adherence.
Education, Qualifications, Skills and Experience
Essential
- Bachelor or above in medical, pharmaceutical, and biological science and equivalent.
- At least 3 years’ experience in clinical operations or other related fields, including 2 years’ experience in HGR management.
- Solid knowledge of drug development and local regulations.
- Good communication and collaborative skills.
- Have ability to prepare and deliver study related training materials
- Fluent in both oral and written English.
【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.
