天津招聘

岗位职责：1.Utilize current electronic document management and publishing technologies to assemble and publishdossiers according to regulatory requirements for paper and electronic submissions with a high degree ofindependence. 2.QC electronic and paper submissions to ensure compliance with company and applicable health agencyrequirements.3.Maintain openly, timely and effective communications with all publishing contributors and responsible RAprofessional, to ensure timely delivery of dossier components and/or complete dossier for submission.4. Participate on special projects and process improvement initiatives, as needed 5. Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas任职要求：1.Regulatory Affairs competencies and proficiency levels vary based on role and may include: AppliedTechnical Knowledge, Business Acumen, Decision Making and Prioritization, External Focus, Leading andInfluencing, and Persuasive Communication2.Therapeutic area and product knowledge, understanding of drug development process preferred3.Demonstrated project or submission management capabilities preferred4.Experience in pharmaceutical industry submission publishing or related technical skills required5.Familiarity with Industry trends and forums, FDA and/or EU, and ROW regulations & guidelines required6.Good working knowledge of Document Management Systems i.e. Documentum, Microsoft Word, Adobe, PDFManipulation Tools i.e. ISI Toolbox, and related submission publishing tools (i.e. Insights Publisher) required7.Experience with document formatting, word processing, use/applications of templates and ensuringsubmission readiness (i.e. bookmarking, hyperlinking and navigational aids) preferred8.Sound understanding of information management concepts and tools needed to support business areapreferred9.Practical understanding of evolving technologies in support of business area preferred10.Technical skills and experience to solve publishing/document processing issues preferred11.Exceptional interpersonal, teamwork, and communication skills required12.Exercises good judgment and communicates effectively with varied levels of the organization required13.Demonstrated ability to work effectively in a matrix environment preferred

主要内容

1、负责药品注册资料的整理及跟进工作；

2、负责收集国内外药品注册相关法律、法规，并向公司其他部门提供相关支持；

3、负责其他注册编辑相关的工作。

任职要求：

1、本科及以上学历，2年以上相关行业工作经验；

2、掌握必要的新药研发相关知识，了解国内、国外药品注册相关法律法规；

3、有较强的沟通协调能力、抗压能力，以及较强的责任心和团队意识。

4、英语沟通能力

上海外服（四川）人力资源服务有限公司（简称“上海外服（四川）”）成立于2007年，由外服控股旗下全资子公司上海外服（集团）有限公司（控股方）与四川省人社厅下属事业单位四川省外资企业中方雇员事务所共同出资组建。
依托母公司38年丰富的服务实践和深厚的专业底蕴，秉承“筑桥引路、聚才兴业”的企业使命，上海外服以“咨询+技术+服务”为价值体系，聚焦“人事管理、薪酬福利、招聘及灵活用工和业务外包”四项主营业务。目前，上海外服（四川）公司正在为近3,500家各类企业和近70,000名雇员提供专业的人力资源服务，服务网点遍布全省21个地市州，为各类企业提供融合本土智慧和全球视野的全方位人力资源解决方案。