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職位描述：
job description：
- be responsible for developing clinical development strategy and plan (including protocols) for china registration purposes
- be responsible for selecting study sites and investigators in partnership with clinical operation
- be the leading physician and responsible of analyzing, interpreting and writing clinical study results in partnership with other key functions
- be a clinical science expert and supporting the regulatory filing and registration
- be a clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given compound
- be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
- responsible for interacting and communicating with china kols.
qualification
- medical degree
- medical training
key skills required
- deep knowledge in medical;
- strategic thinking and problem solving skills
崗位職責(zé)：
-負責(zé)為在中國注冊的新藥制定臨床發(fā)展戰(zhàn)略和計劃；
-負責(zé)與臨床團隊合作，選擇研究地點和患者；
-作為主要醫(yī)生，負責(zé)分析、解釋和撰寫臨床研究報告；
-作為臨床醫(yī)學(xué)專家，為合規(guī)的檔案和登記備案等相關(guān)工作提供支持；
-成為臨床科學(xué)專家，主導(dǎo)與監(jiān)管部門的關(guān)于臨床科學(xué)主題的相關(guān)探討；
-作為臨床科學(xué)醫(yī)生，為臨床操作同事提供關(guān)于方案設(shè)計問題的咨詢，及回答實驗患者提出的相關(guān)問題；
-負責(zé)與中國專家的互動和溝通。
任職要求：
1.臨床醫(yī)學(xué)或相關(guān)專業(yè)背景，碩士及以上學(xué)歷；
2.可接受無新藥開發(fā)經(jīng)驗的人員應(yīng)聘。公司將提供到美國培訓(xùn)的機會，全面系統(tǒng)學(xué)習(xí)新藥臨床研究相關(guān)知識。