Responsibility
1.Responsible for the finalization of non-clinical registration dossier and client communication.
負責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.
根據非臨床相關指導原則撰寫或審核非臨床申報資料(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和流程。
2.Be familiar with FDA/NMPA and other relevant regulatory authorities.
熟悉 FDA/NMPA 及其他相關監管機構。
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驗,主導過多個IND產品的非臨床申報,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、藥理毒理或相關專業,本科以上學歷。
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非臨床注冊經驗,有非臨床試驗機構經歷者優先
二線城市均可,homebase辦公