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Accountabilities：

1.Work with global RWS experts to finalize the study protocol.

2.Coordination with internal and external statistics expert to finalize the related statistical documents.

3.Coordinate with cross functional team, especially collaborate with medical affairs team to follow the discussion with leading PI for RWS.

4.Collaborate with CRO to facilitate RWS submission/review and comments feedback.

5.As one team to understand good RA strategy if the RWS maybe considered to support for bridging study or local production.

6.Lead RWS data use for registration if CDE agreed.

Knowledge/ Academic Qualification:

1.With adequate knowledge of clinical design and statistical discussion

2.Master's degree or higher in biomedical sciences, pharmacy, epidemiology, or related field; Medical background is preferred.

3.At least 5 years of project management experience in pharmaceutical or CRO companies, with a preference for oncology experience; with adequate knowledge of clinical design.

4.Familiarity with RWE study design, data collection, and analysis methods, with strong statistical analysis skills.

5.Excellent project management and team leadership skills, capable of driving project progress in a fast-paced environment.

Skills:

1.Outstanding communication and collaboration skills, able to effectively interact with stakeholders at various levels.

Experience:

1.With Oncology clinical develop experience in global pharmaceutical companies

2.Experienced CDE consultation as the main clinical speak person.

3.Successful experience of RWS in supporting/accelerating product registration

4.Sound reasonable regulatory experience in China is a plus.