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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床申報資料（CTD格式中的模塊2.4、模塊2.6，模塊4 報告等) 。
Qualifications
1.Be familiar with the drug rgistration non-clinical regulations and process.
熟悉藥品注冊非臨床法規(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)管機構(gòu)。
3.Good command of computer skill for paper works.
熟練使用電腦進行文字編輯工作。
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,主導(dǎo)過多個IND產(chǎn)品的非臨床申報，有成功獲批案例。
5.Good English in reading and writing.
良好的英語讀寫能力。
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.
熟悉非臨床申報資料的撰寫，需要有中美IND非臨床注冊經(jīng)驗，有非臨床試驗機構(gòu)經(jīng)歷者優(yōu)先
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