英語(yǔ)蔣老師
作者：梅奧醫(yī)學(xué)翻譯 | 關(guān)注：2023-05-12 14:36:58 | 關(guān)注：
性別 ：男
教育背景 ：
2004-2008 哈爾濱醫(yī)科大學(xué) 藥學(xué)專業(yè) 本科
工作經(jīng)歷 ：
工作時(shí)間 ：2009.03-2011.11
公司名稱 ：浙江華海藥業(yè)股份有限公司
職位 ：制劑注冊(cè)專員
工作時(shí)間 ：2011.11-2012.05
公司名稱 ：揚(yáng)子江藥業(yè)集團(tuán)
職位 ：制劑注冊(cè)主管
工作職責(zé) ：
- 國(guó)內(nèi)市場(chǎng)：制劑項(xiàng)目注冊(cè)申報(bào)、在研項(xiàng)目管理以及國(guó)內(nèi)藥監(jiān)部門(mén)交流溝通
- 美國(guó)市場(chǎng)ANDA：項(xiàng)目申報(bào)技術(shù)資料支持（CMC部分）
- 歐洲在研項(xiàng)目：客戶接待、溝通及項(xiàng)目總結(jié)匯報(bào)（英文）
- 藥品技術(shù)轉(zhuǎn)移項(xiàng)目（進(jìn)口轉(zhuǎn)國(guó)內(nèi)）（技術(shù)資料翻譯、整理和編寫(xiě)）：
制劑和原料相關(guān)技術(shù)資料整理翻譯：參考法規(guī)要求，協(xié)調(diào)技術(shù)部門(mén)對(duì)產(chǎn)品生產(chǎn)場(chǎng)地轉(zhuǎn)移后的技術(shù)參數(shù)變化進(jìn)行對(duì)比、評(píng)估和整理，對(duì)相關(guān)技術(shù)資料進(jìn)行整理翻譯。
原輔料檢驗(yàn)及對(duì)照品標(biāo)化：與省檢驗(yàn)所及客戶完成必要的原輔料和包材檢驗(yàn)工作。
- 其他
前期初步的項(xiàng)目調(diào)研工作，協(xié)調(diào)各部門(mén)完成相應(yīng)的項(xiàng)目調(diào)研。整理項(xiàng)目立項(xiàng)資料，制定項(xiàng)目注冊(cè)策略。制定初步項(xiàng)目研發(fā)時(shí)間表，保證項(xiàng)目進(jìn)度。
公司合作項(xiàng)目注冊(cè)支持：
為公司擬開(kāi)發(fā)項(xiàng)目提供項(xiàng)目支持
部門(mén)團(tuán)隊(duì)建設(shè)：
按照公司發(fā)展規(guī)劃，負(fù)責(zé)部門(mén)隊(duì)伍建設(shè)，培養(yǎng)挖掘注冊(cè)人才。
培訓(xùn)經(jīng)歷 ：
- 浙江省藥監(jiān)局藥品注冊(cè)專員培訓(xùn)
- 杭州銷售公司組織的優(yōu)秀員工訓(xùn)練營(yíng)
- 公司及部門(mén)組織GMP、分析方法、研發(fā)流程等培訓(xùn)
個(gè)人能力 ：
- 具備較強(qiáng)的交流溝通協(xié)調(diào)能力及團(tuán)隊(duì)協(xié)作精神；
- 較強(qiáng)的中英技術(shù)資料互譯能力及口語(yǔ)交流翻譯能力；
- 熟悉理解國(guó)家相關(guān)法律法規(guī)，能夠?qū)⑵溥\(yùn)用于日常工作中，為公司提供法規(guī)事務(wù)支持；
- 具備一定的項(xiàng)目管理能力和經(jīng)驗(yàn)，能夠保證項(xiàng)目的順利進(jìn)行和計(jì)劃的實(shí)施；
- 能夠很好的協(xié)調(diào)各部門(mén)工作，最大地促進(jìn)項(xiàng)目或工作的開(kāi)展；
- 熟練掌握日常各種辦公軟件。
Cell phone: 15152403302
Email: Jqx4622768@163.com
Education:
Haerbin Medical University
Bachelor Degree in Pharmaceutical Science
Experience:
- 2008.07~2011.11 Formulation RA in Zhejiang Huahai Pharmaceutical Co., Ltd.
- 2011.11~2012.05 Formulation RA in Yangtze River Pharmaceutical Group
Domestic Product Registration:
Registrations of generic products in China: Deal with issues arisen from dossier submission and product testing, including raw material, excipients and packaging materials testing, specification review etc.
Regulatory Affairs Support for Foreign Projects:
- ANDA Application: Support Huahai US colleagues with CMC material translation and preparation for ANDA application. Draft dossier submission timetable. Coordinate with colleagues from other departments to ensure on-time submission of required documentations.
- EU projects: Reception of on-site inspection by SFDA or EU customers. Follow up product development and communicate with project team members to enhance product development process.
Product evaluation, task distribution and setting the timetable for each responsible department. Finished the documentation preparation for a technology transfer from foreign site to domestic site:
Basics Skills:
- Excellent oral English and translation skills and communication skills with team members, colleagues from other departments or clients from other countries.
- Have a good understanding of domestic drug product registration environment.
- Familiar with SFDA regulations and provincial regulations with appropriate understanding to promote product developing.
- Fluent English-Chinese translation and interpreting skills.
- Highly self-motivated person with a strong sense of responsibility;
- Team player with a trusting manner. High adaptation and learning capability;
- Open, honest, friendly and hard working. Overall planning ability;