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Global Head of HGR Compliance and Management

Location Shanghai Downtown, Shanghai Municipality, China Job ID R-076439 Date posted 03/05/2020

Global head of HGR Compliance and Management group will serve as the secretary of the HGR governance committee to facilitate cross functional interaction and final decision making for HGR related activities. The person will also act as the key representative of HGR governance committee in relevant global or local governance forum including but not limited to quality council, HBS governance and CPMC, to lead or present related topics of HGR compliance.

The incumbent will lead a group of HGR experts to carry out activities including but not limited to:

  • Maintain and continuously update global HGR SOP in response to changes in HGR regulation. Global Head of HGR Compliance and Management serves as the HGR Process Owner and lead the interactions with external key stakeholders.
  • Provide timely and robust interpretation of any HGR regulatory update, develop related training package and provide HGR regulatory advice to HGR relevant activities.
  • Lead and coordinate HGR sponsor inspections.
  • Develop metrics tool for measuring compliance and facilitate compliance report review at the governance committee.
  • Monitor QI reporting and resolution of HGR non-compliance on a regular basis.
  • Generate HGR dashboard to monitor HGR submission/approval status and risks.
  • Develop QC checking tool to enable study teams to perform QC checking before HGR submission.

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.

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  • Project, Change, Business Improvement and Strategy Management, Shanghai Downtown, Shanghai Municipality, ChinaRemove

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