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银虫 (小有名气)

应助: 0 (幼儿园)
金币: 478
帖子: 108
在线: 15.4小时
虫号: 1196481
注册: 2011-01-26
性别: MM
专业: 内分泌系统疾病/代谢异常与

[交流] 某大型外企招电子文档专员

具体工作地点:

北京国贸

薪金:

面谈

联系方式:

yukili@chinacareer.com

Job Title 职位名称: Electronic Document Specialist (eDS)

1. User support of the eDMS (electronic data management system) and management of the clinical document lifecycle from study code creation through e-approval.
2. Identify and incorporate appropriate information into document templates managed by Medical Writers
3. Implement editing and formatting of clinical documents for consistency and compliance with standards, guidelines, regulatory and electronic requirements to ensure submission-readiness of the document. When necessary, assist in the reformat to correct document structure to meet company standards.
4. Assemble, publish and QC Clinical Study Reports (CSR) using established tools, processes, standards and guidelines for submission readiness.
5. Participate in the development of training material and assist in delivering training to the end-users.
6. Work together as a team sharing knowledge and expertise. Understand and implement department processes as part of normal work flow. Participate in Clinical Team Meetings (CTT, Submission task force, CRO) and cross-functional meetings (working groups) as a representative of CEDM, as needed.
7. Embrace new tools, software and technology as they become available and be involved in the testing of those new tools, as required.

JOB-HOLDER ENTRY REQUIREMENTS
Education & Experience:
A candidate with a Bachelor degree in Life Science, Computer Science, Communication, Information Technology or Related field.
A 2-4 years’ experience in pharmaceutical industry is an asset

Core competencies:
Good command of English, especially verbal communication
Technically competent in the use of document management tools such as WORD, EXCEL, Acrobat, Power Point, CoreDossier, and Documentum. Understanding of ICH guidelines for the Electronic Common Technical Document (eCTD)
Proactive, accountable, detail and deadline oriented, organizational ability and follow-up skills
Interpersonal communication skill
A good team player and good planner

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