【職位描述】
1. Establish and lead labeling management process from new product introduction to change management after launch including both clinical and Industry product;、
建立和領導標簽管理,范圍包括臨床和工業(yè)產品從新產品上市到產品變更管理。
2. Closely work with Global PLD to align practice and adapt to local requirement(for example UDI) if need;
與總部的標簽管理團隊緊密合作,根據(jù)本地要求(例如UDI)達成一致的操作。
3. Proactivity work with Global PLD, Regulatory Affairs, Marketing and Application Specialist to finalize package insert and labeling content translation and review according to China regulation requirement;
根據(jù)中國法規(guī)要求,主動與總部標簽團隊,注冊事務部,市場部以及產品應用專員合作完成產品說明書和標簽的翻譯和校對工作。
4. Closely work with supply chain team to manage the product label related data updating
和供應鏈密切合作,管理好標簽相關數(shù)據(jù)的更新。
5. Maintain the product label master data, and deliver related information to cross function as well as upload to related platform according to local regulation requirement when needed
維護標簽主數(shù)據(jù)庫, 需要時將相關信息傳遞給相關部門以及根據(jù)法規(guī)要求上傳至相關平臺。
【任職要求】
1. Education background: biological Engineering, Pharmaceutical related are preferred. / 教育背景:生物工程,藥學等相關專業(yè)優(yōu)先
2. 2~5 years of RA/QA working experience or product labeling management preferred. / 2~5年RA/QA工作經(jīng)驗者和標簽管理工作經(jīng)驗者優(yōu)先
3. Good command of English in both written and oral. /書面口頭英語熟練
4. Good communication and interpersonal skills. / 良好的溝通技能
5. Team work and take initiatives. self-discipline and work independently / 團隊合作精神、主動工作、具有較強自律能力并能獨立工作
6. Work under pressure. / 抗壓能力強
6. Support the internal and external audit支持內部和外部審核。
生物梅里埃公司創(chuàng)建于1963年,公司依賴自身的科技研究和工業(yè)生產資源,始終致力于開發(fā)作為醫(yī)療和工業(yè)用途的體外診斷產品。集團專門設計、開發(fā)、生產和推廣應用在臨床和工業(yè)的系統(tǒng)。生物梅里埃的診斷系統(tǒng)是由試劑、儀器和軟件組成,主要為傳染病、工業(yè)微生物控制、心血管病和腫瘤病等四個主要策略性領域進行設計。在2010年,公司銷售額已達到13億5千7百萬歐元,共有18個生產基地和11個研究中心,分布于歐洲、北美洲和南美洲。至2011年集團員工已超過7,000人,遍布全球39個國家和地區(qū)。生物梅里埃公司產品有兩個主要應用領域:臨床和工業(yè)。臨床市場占總銷售額的85%,而工業(yè)市場占15%。工業(yè)的應用領域主要集中在食品、藥品和化妝品的微生物分析,其市場增長非常迅速。生物梅里埃是全球體外診斷領域的第七大生產商。 World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions(systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety. bioMérieux is present in 43 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l’Etoile, near Lyon, in France. Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux employees who already identify with these values!