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[上海]辉瑞研发中心药品注册支持部

  1. 发布时间:2017-05-19
  2. 工作地点:上海
  3. 职位类型:兼职实习
  4. 来源:上海交大BBS
  5. 职位:实习生
[原帖] 发信人: Jiangzi(江海行人), 支持应届生▉ying jie sheng.com▉
标  题: 【辉瑞】 研发中心招实习生一枚 地点张江 
发信站: 饮水思源 (2017年05月19日16:17:40 星期五)

药品注册支持部实习生——内部推荐,简历速度投过来吧~~ 

人数:1名
工作地点:上海张江
实习期:至少6个月
出勤:一周4天及以上
简历请投递:1062523644@qq.com

主要工作职责:
	对辉瑞全球临床研究(包括临床研究报告 、安全报告及研究机构启动资料等)
以及药品注册文件(包括注册申报及上市后许可资料等)进行编辑出版和质量控制 
	参照各国家和地区关于药品注册要求,保证注册文档的高质量、时效性及合规性
 
	参与对各业务流程的改进及优化
基本任职条件: 
	生物、医学、药学、计算机、信息管理、英语专业大学及以上学历 
	注重细节及优秀的组织协调能力 
	按照不同的技术要求,同时处理多个任务的能力 
	能独立协调和管理项目时间进度,确保项目按时完成 
	熟练的英文听、说、读、写能力,熟练使用MS Office


Job Title: Publishing and Product License Support Intern (CRDC) 
Dept.: Publishing and Product License Support (PPLS)
Term: at least 6 Months 
Vacancy: 1

General Job Description: 
•	Responsible for Dossier metadata entry via Pfizer submission managemen
t tool and system
•	Responsible for pre-publishing Dossier preparation by documentation ex
porting, merging, splitting and format conversion
•	Dossier archive post publishing and dispatch
•	Project manage and coordinate compilation, quality control, approval a
nd post-approval processes associated with development of Pfizer global CSRs
•	Supporting to ensure Pfizer maintains compliance by delivering the por
tfolio of one or multiple applicable regulatory obligations
•	Other business needs to ensure business compliance


Job Requirements:

•	University student, preferably majoring in Pharmacy, Biology, Life Sci
ence, Business or Information Technology or other related fields;
•	In depth knowledge of drug development and regulation;
•	Fluent in English listening, reading, writing and speaking; 
•	Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat;
•	Proven technical aptitude and ability to quick learn and use new soft 
wares, regulations and quality standards;
•	Ability to work with accuracy and attention to details;
•	Quick learner with ability to multi-tasks;
•	Preferred to work at least 4 full days a week;
•	Internship duration: at least 6 months.

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※ 来源:·饮水思源 bbs.sjtu.edu.cn·[FROM: 204.114.196.21]
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