RA Manager
上海翰升人力资源管理有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2012-11-02
- 工作地点：北京
- 招聘人数：1
- 职位类别：药品注册
职位描述
1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Process before SFDA registration submission, 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 manager should upload approved labeling file to Live link to improve labeling updates;manager takes a lead for labeling issue solution, and answer questions labeling related.
?Participate in project planning activities, assessing necessary resources and estimating timelines for documentation development and production.
?Coordinate activities Product Labeling in France when necessary.
?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.
?Compile reports, spreadsheets, and documentation as needed to support departmental workflow.
?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.
?Ensure a system/architecture to archive and organize electronic source files (and graphics if applicable).
?Track and implement change requests, errors, issues, and requirements logged against documentation.
?Define and manage final deliverables and surrounding processes, following appropriate change management processes.
?Support RA registration for new, renew and modification on labeling.
?
2. KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
?4-6 working experience in related field.
?Good communication.
Education & Knowledge:
?Bachelor Degree or above in Biology, Microbiology, Medical related.
?Good writing.
?Excellent in English.
Process before SFDA registration submission, 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 manager should upload approved labeling file to Live link to improve labeling updates;manager takes a lead for labeling issue solution, and answer questions labeling related.
?Participate in project planning activities, assessing necessary resources and estimating timelines for documentation development and production.
?Coordinate activities Product Labeling in France when necessary.
?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.
?Compile reports, spreadsheets, and documentation as needed to support departmental workflow.
?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.
?Ensure a system/architecture to archive and organize electronic source files (and graphics if applicable).
?Track and implement change requests, errors, issues, and requirements logged against documentation.
?Define and manage final deliverables and surrounding processes, following appropriate change management processes.
?Support RA registration for new, renew and modification on labeling.
?
2. KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
?4-6 working experience in related field.
?Good communication.
Education & Knowledge:
?Bachelor Degree or above in Biology, Microbiology, Medical related.
?Good writing.
?Excellent in English.
公司介绍
翰升专注于为在中国的生命科学行业提供专业的招聘服务。
我们的招聘服务在行业领域细分为化学制药、生物制药、医疗器械、动物保健以及化工、食品等相关生命科学行业。我们提供该行业从初级职位到高级职位的全方位招聘咨询服务，涉及工厂、研发以及商业各职能部门。
公司网址：www.talentup-hr.com
我们的招聘服务在行业领域细分为化学制药、生物制药、医疗器械、动物保健以及化工、食品等相关生命科学行业。我们提供该行业从初级职位到高级职位的全方位招聘咨询服务，涉及工厂、研发以及商业各职能部门。
公司网址：www.talentup-hr.com
联系方式
- 公司地址：上班地址：重庆江北