Technical Writer & Coordinator
柯惠(中国)医疗器材技术有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2013-09-17
- 工作地点:上海
- 招聘人数:若干
- 职位类别:其他
职位描述
Position Summary:
In order to reduce the lead time of Artworks process through reducing draft preparation lead time and review cycles, and to meet the needs of submitting docs for category application/type test of CFDA in early stage of PDP, a dedicated, experienced, knowledgeable role of technical writer & coordinator is highly needed.
PRINCIPAL ACCOUNTABILITIES:
· Keep work contact with contact points of Artworks teams in different GBU and get trained/knowledgeable quickly on the Artworks’ (including IFU, Manual, User Guide, and Label, etc) SOP, requirements to Job Requisition in different GBU.
· Generate templates/formats of Artworks of different product category, which is well aligned with the practice in different GBU.
· For each project, train different functions (PM, Marketing, RA, QA, Designing, Packaging, Clinic Affair, etc) with the information elements for Artworks corresponding to the functions and align with the functions on the common due date of providing the information elements to him/her.
· Draft the Artworks docs of both English and Chines version, have proof reading by different functions, submit to Artworks teams of GBUs, update the draft when necessary, track and respond to the processing in GBU till end of the tasks.
Provide timely Artworks docs with different version (draft/final, English/Chinese) for CE/510K/CFDA tests, Product Category application, Clinical Study, and Registration submission at different time according to project schedule.
EXPERIENCE:
· Minimum of 3 years relevant experience;
· Education in Engineering, Scientific or Technical discipline required.
· Medical device experience strongly preferred.
Education Required:
· Batchelor of Science or Engineering required.
Education Preferred:
· M.S. preferred.
JOB COMPETENCIES:
· Fluent in both English and Chinese
· Good Writing skill in technical area in both English and Chinese
· Time Management with multi projects at the same time
· Good communication skills
· Customer Focus
· Self-starter with limited supervising
· Good at using Office software and any Artworks software
In order to reduce the lead time of Artworks process through reducing draft preparation lead time and review cycles, and to meet the needs of submitting docs for category application/type test of CFDA in early stage of PDP, a dedicated, experienced, knowledgeable role of technical writer & coordinator is highly needed.
PRINCIPAL ACCOUNTABILITIES:
· Keep work contact with contact points of Artworks teams in different GBU and get trained/knowledgeable quickly on the Artworks’ (including IFU, Manual, User Guide, and Label, etc) SOP, requirements to Job Requisition in different GBU.
· Generate templates/formats of Artworks of different product category, which is well aligned with the practice in different GBU.
· For each project, train different functions (PM, Marketing, RA, QA, Designing, Packaging, Clinic Affair, etc) with the information elements for Artworks corresponding to the functions and align with the functions on the common due date of providing the information elements to him/her.
· Draft the Artworks docs of both English and Chines version, have proof reading by different functions, submit to Artworks teams of GBUs, update the draft when necessary, track and respond to the processing in GBU till end of the tasks.
Provide timely Artworks docs with different version (draft/final, English/Chinese) for CE/510K/CFDA tests, Product Category application, Clinical Study, and Registration submission at different time according to project schedule.
EXPERIENCE:
· Minimum of 3 years relevant experience;
· Education in Engineering, Scientific or Technical discipline required.
· Medical device experience strongly preferred.
Education Required:
· Batchelor of Science or Engineering required.
Education Preferred:
· M.S. preferred.
JOB COMPETENCIES:
· Fluent in both English and Chinese
· Good Writing skill in technical area in both English and Chinese
· Time Management with multi projects at the same time
· Good communication skills
· Customer Focus
· Self-starter with limited supervising
· Good at using Office software and any Artworks software
公司介绍
About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
联系方式
- Email:Alex.meng@covidien.com
- 公司地址:上班地址:上海市浦江镇陈行路2388号浦江科技广场3号楼