长沙招聘

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Process before SFDA registration submission, PLD is responsible to follow up with AS and Marketing on technical translation and validation to improve quality of labeling as well as to secure efficiency of registration key document preparation; Process after registration approval, PLD should upload approved labeling file to Live link to improve labeling updates; PLD takes a lead for labeling issue solution, and answer questions labeling related.

1.Keep close eye to SFDA new regulation and notice for the change impact on labeling.
2.Support RA registration for new, renew and modification on labeling
3.Support PLD manager on labeling issue management.
4.Maintain database to sure its accuracy and most updated.
5.Internal Q&A for labeling concerns
6.Participate in project planning activities, assessing necessary resources and estimating timelines for documentation development and production.
7.Ensure consistency of processes and deliverables. To do so, write and format documentation according to established templates (provided by Corporate PLD) and departmental styles and standards. Proofread documentation for accuracy and adherence to departmental styles and standards.
8.Compile reports, spreadsheets, and documentation as needed to support departmental workflow.
9.Responsible for translation coordination and consolidating and reconciling all markups from internal reviewers during translation process. Schedule and facilitate technical review meetings. Regularly interface with cross-functional subject matter experts to ensure accuracy of deliverables.
10.Track and implement change requests, errors, issues, and requirements logged against documentation.
11.Define and manage final deliverables and surrounding processes, following appropriate change management processes.



KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB

Experience & Personality:
1.2 working experience in related field.
2.Good communication

Education & Knowledge:
1.Bachelor Degree or above in Biology, Microbiology, Medical related.
2.Good writing
3.Excellent in English

      生物梅里埃公司创建于1963年，公司以来自身的科技创新和工业生产资源，始终致力于医疗和工业用途的体外诊断产品。生物梅里埃的诊断系统由试剂、仪器和软件组成，主要围绕感染性疾病、工业微生物、心血管病和肿瘤四个战略领域设计。生物梅里埃的使命是通过体外诊断，为全球公共卫生事业做出贡献。
      目前，生物梅里埃在全世界拥有19个工业生产工厂；20个研发基地；业务遍及世界六大洲160个国家，在44个国家和地区设有分支办事机构；全球雇员近13000人。凭借55年的经营，生物梅里埃如今在全球体外诊断行业扮演着重要的角色，在全世界诊断企业排名中位列前十，是临床微生物学和工业微生物学领域的翘楚。
      放眼未来，生物梅里埃将继续秉承传统、恪守承诺，全力为客户研发和提供***整体解决方案，力争成为推动全球公共卫生事业发展的领导者。