Position: Medical Project Lead
Reporting to: Medical Affairs Effectiveness Manager
Working Location: Shanghai
JOB SUMMARY:
Medical project lead (MPL) is required to systematically manage the study projects related with medical affairs to ensure a consistent level of good quality of work; the MPL also responsible for medical review for educational grant, sponsorship etc. to ensure the scientific purpose and high medical standards of commercial activities. As such, a good understanding of clinical research and project management capability are mandatory.
KEY RESULT AREAS & JOB ACTIVITIES/ TASKS:
- Develop management system and standard procedures for medical affairs related projects such as IIR management etc.; and ensure its effective implementation and high quality.
- Communicate regularly and maintain good cooperation with IIR manager/investigator to ensure the IIR’s quality and timeline according to plan.
- Work as IIR Coordinator to submit IIR required documents to INSPIRE system through cooperation with IIR manager. Archived all required documents adhere to SOP.
- Work as IIR Coordinator to follow-up the IIR status and inform regional/global review comments and the updated approval status to IIR manager timely.
- Work as Phase IV/INS Coordinator to communicated and cooperation with CR to support the project timeline according to plan.
- Follow-up study activities through ongoing tracking, report study status monthly.
- Document management for MA related projects such as protocol synopsis, contract and etc.
- Medical review of educational grant, sponsorship etc. to ensure the scientific purpose and high medical standards of commercial activities.
BACKGROUND REQUIREMENTS:
- At least bachelor degree in clinical medicine; MD degree is preferred.
- At least 1 year’s clinical research associate experience in pharmaceutical industry, medical affairs working experience is preferred.
- Good project management skill and systemic thinking.
- Good communication and coordination skill.
-----------------------------------------------------------------
E-Mail:[email protected]
Tel:021-61600783
