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Responsibility 1.Responsible for the finalization of non-clinical registration dossier and client communication. 負(fù)責(zé)非臨床注冊(cè)資料的定稿和客戶溝通。 2.Write or review non-clinical register dossiers (module 2.4, module 2.6, module 4 reports in CTD format)) in accordance with non-clinical guidelines. 根據(jù)非臨床相關(guān)指導(dǎo)原則撰寫或?qū)徍朔桥R床申報(bào)資料（CTD格式中的模塊2.4、模塊2.6，模塊4 報(bào)告等) 。 Qualifications 1.Be familiar with the drug rgistration non-clinical regulations and process. 熟悉藥品注冊(cè)非臨床法規(guī)和流程。 2.Be familiar with FDA/NMPA and other relevant regulatory authorities. 熟悉 FDA/NMPA 及其他相關(guān)監(jiān)管機(jī)構(gòu)。 3.Good command of computer skill for paper works. 熟練使用電腦進(jìn)行文字編輯工作。 4.At least 3-5 years non-clinical working experiences, leading the non-clinical register dossier of several IND products, with successful approval cases. 3-5 年藥品非臨床工作經(jīng)驗(yàn),主導(dǎo)過(guò)多個(gè)IND產(chǎn)品的非臨床申報(bào)，有成功獲批案例。 5.Good English in reading and writing. 良好的英語(yǔ)讀寫能力。 6.Pharmacy, Pharmacology/Toxicology or relevant major with at least Bachelor’s degree. 藥學(xué)、藥理毒理或相關(guān)專業(yè)，本科以上學(xué)歷。 7.Familiar with the writing of non-clinical register dossier module 2.4/2.6 and module 4 report, need to have Chinese and US IND non-clinical registration experience,the experience in non-clinical trial institutions is preferred. 熟悉非臨床申報(bào)資料的撰寫，需要有中美IND非臨床注冊(cè)經(jīng)驗(yàn)，有非臨床試驗(yàn)機(jī)構(gòu)經(jīng)歷者優(yōu)先 二線城市均可，homebase辦公