工作內容
1. Protocol, ICF and CRF design and development.
2. CSR and clinical investigator's brochure writing.
3. CTD writing for submission e.g. IND, NDA …
4. Integrated report, annual update, special science report writing.
5. Regulatory GAP analysis.
6. Product evaluation.
7. Scientific literature search, review and information integration.
8. Complete other tasks or assignments requested by the director.
工作說明
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工作縣市:臺北市
- 上班地點:台北市南港區
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工作待遇:面議
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上班時段:日班,
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需求人數:1
條件要求
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工作經歷:
8年以上
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學歷要求:博士
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科系要求:
藥學相關
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專長需求:
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擅長工具:
- 具備駕照:
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其他條件:
1. Required working experiences: biotech or pharma for 5 years.
2. Experience in the trial design, data analysis and conduct of clinical trials.
3. Experience in clinical document writing, preparation, or review.
4. Well understandings for medical/ clinical terms.
5. Adequate scientific logic and basic statistic concepts.
6. Excellent English writing and presentation, listening, communication skills.
7. Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
8. Willing to receive training and develop career in medical scientific field.