Evidence Generation，MA Director
Lead MA Clinical Study Operations team (CSO) for project management, Statistician team; functionally lead the Publication Team (dotted report) in China to utilize publication resource locally under the guidance from Global publication functional team, and others if needed determined by VP, China MA.
The role and responsibility of above functions is to maximize the value of Medical Strategy and Plan aligned evidence delivery and expertise support, which is across medical affairs by ensuring its quality, on-time delivery within budget through effective management of the projects as well as the people under responsibility.
The role has people responsibility will spend about 50-60% of time to provide supervision and guidance to team members.
DUTIES & RESPONSIBILITES / 主 要 职 责
Manager for CSO PM team, Statistician team ; lead publication team
Manage resource to different teams
Project assignment in the most efficient way
Ensure objective setting, performance review and IDP planning & dialogue is in place for all direct reports
Accountable for induction, coaching, mentoring and projects co-management of new team members
Ensure all direct reports are qualified for related tasks after appropriate training
lead the Publication Team in China to utilize publication resource locally under the guidance from Global publication functional team
Lead and organize regular review and knowledge sharing meeting
Be responsible for on- time, quality, within budget delivery of MA clinical study programs for key products
Forecast timelines, budget & FET recourse.
Lead team successful implementation of the CSO (NIS, ESR, others) as top priority for the area of responsibility.
Monthly track and manage to agreed project timelines, budget and resource to highlight significant variance and take appropriate actions to get project on track.
Lead team effective and consistent project management of the initiatives and/or global & regional team to ensure up-to-date information captured
Ensure SOP/local regulation compliance followed
Consistency on critical managerial skills (but not limited to) accountability, sense of urgency, ability to demonstrate resiliency, clear understanding of team strengths and weaknesses, opportunity maximization, risk management planning, inspiration and deliver as a team.
Be responsible for Statistics qualification and technically support to MA.
Ensure Statistician continuously support in study related activities, e.g.: review, data analysis/check for on-going study if needed, and close data check and review for SAR and CSR at the end of study.
Smoothly set up a transparent platforms co-work with different Medical teams for well cooperation during the projects.
Exchange expertise with KOLs if needed in statistician area in or out of AZ.
Company policy or/and process followed.
Be responsible for publication Team in China under guidance of global team
Lead the publication Team:
Utilize the resource locally
Set up the publication plan aligned with TAs strategy and plan.
Closely work with and get guidance from global publication team for China publication process set-up and function development.
Planning, writing, editing, reviewing and coordinating the publication of scientific data through peer-reviewed journals or/and forums and/or regulatory documents in partnership with other team members.
Exhibits flexibility in moving across development and preparation of multiple document types.
Align timelines and contents with other team members.
Establish and maintain local process/working instruction
Improve local process
Provide training to relevant people to make sure involved parties fully aware of the company SOPs, policy/process
Follow MA quality requiremen
Build and Maintain KOLs through scientific programs
Work with Medical on KOL/potential investigators build up and maintain including appropriate investigators, and any other and hoc experts related.
Member of MA leadership team
Active participate MA Management Team meetings and contribute for Medical Affairs Functional development.
Clear partner with Medical affairs partners on creating a healthy work environment, appropriate time and priority management as well as retention of top talent.
Share appropriate information with teams.
Perform other tasks assigned by line manager
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 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.