职位详情
(高级)医学科学顾问 (Sr)Medical Scientific Advisor-RWE
2.5-3万·13薪
法国施维雅
北京
3-5年
硕士
06-26
工作地址

施维雅(天津)制药有限公司

职位描述

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

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