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【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(lǐng)導(dǎo)標(biāo)簽管理，范圍包括臨床和工業(yè)產(chǎn)品從新產(chǎn)品上市到產(chǎn)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(biāo)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(biāo)簽團隊，注冊事務(wù)部，市場部以及產(chǎn)品應(yīng)用專員合作完成產(chǎn)品說明書和標(biāo)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(yīng)鏈密切合作，管理好標(biāo)簽相關(guān)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(biāo)簽主數(shù)據(jù)庫, 需要時將相關(guān)信息傳遞給相關(guān)部門以及根據(jù)法規(guī)要求上傳至相關(guān)平臺。 6. Support the internal and external audit 支持內(nèi)部和外部審核。 【任職要求】 1. Education background: biological Engineering, Pharmaceutical related are preferred. / 教育背景：生物工程，藥學(xué)等相關(guān)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(biāo)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