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Accountabilities：
1、Clinical development strategy set up: Clinical development plan, medical part of protocol, cross functional alignment.
2、Medical dossier preparation: Medical part of IB, CSR etc.
3、Medical monitoring: Medical review including AE/SAE, protocol deviation, data review. Medical query from PI & CRA.
4、External key stakeholder communication: Communication with external key stakeholder such as TAE, CDE, NMPA etc. with medical support.
5、Cross functional cooperation: Close cooperate with internal stakeholders such as HQ RWE team, PV team, statistic team, strategic team and compliance team etc.
Knowledge/ Academic Qualification:
1、Master’s degree or above in clinical medicine.
Skills:
1、Clinical medical education background preferred
2、Complete GCP training.
3、Fluent both in oral and written English and Chinese
4、Excellent communication skills
5、Familiar with clinical study flow and related policy
Experience:
1、Experience of medical physician role for at least 1 clinical trial is mandatory.
2、More than three years’ experience in R&D pharma. MSA or CRO experience preferred
3、Clinical doctor experience, esp. oncology field experience preferred
Competency：
1、Develop study plan and protocol
2、Knowledge of drug development and clinical trial process
3、Proactive attitude and open minded
4、Facing challenge actively and results driven