台灣雙健維康生技顧問有限公司
Medical Writer/醫學寫作
9/18 Updated
Array
English Required
Full-time
Mid to Senior Level
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市大安區
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
1年以上
Job Description
Medical Writer is responsible for the following tasks:
1. Write and edit clinical development documents, including but not limited to, clinical protocols, investigators brochures, clinical study reports, and master inform consent forms.
2. Write and edit scientific manuscripts and assist the publication process.
3. Under minimal supervision, critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, scientific rigor and absence of bias.
4. Generate and review regulatory documents required for health regulatory agencies, mainly United States Food and Drug Administration (US FDA) and Taiwan FDA (TFDA), and institutional review boards (IRBs).
5. Communicate with and respond to comments from health regulatory agencies and IRBs.
6. Perform and review medical coding primarily using Medical Dictionary for Regulatory Activities (MedDRA), WHO Drug Dictionary and ATC code.
7. Perform and review manual check of data validation.
8. Review subject safety issues, write case narratives and prepare relavent safety reporting documents.
9. Assist the pharmacovigilance activities if assigned.
10. Highly proficient with styles of writing for various documents required by US FDA, TFDA and IRBs.
11. Complete writing assignments in a timely manner. Maintain timelines and workflow of writing assignments.
12. Practice good internal and external customer service.
13. Interact with clients proficiently to coordinate all facets of projects.
14. Generate and review required standard operating procedures (SOPs) as assigned.
Number of Openings
1~2人
Educational Requirements
博士以上
Field of Study Requirements
生物學相關、醫學系相關、藥學相關
Work Schedule
日班
Leave Policy
週休二日
Job Category
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
台北市大安區
其他醫療保健服務業
台灣雙健維康生技顧問有限公司為日本伊藤忠集團旗下 A2 Healthcare Corporation之台灣子公司，主要提供服務為全方位之臨床研究受託服務，包含醫學文件撰寫，台灣、美國及日本之主管機關或IRB送件，試驗監測，資料處理，EDC建置及統計分析服務。公司自2012年成立至今，已累計服務國內外逾45個客戶，執行逾100件臨床試驗。除國內執行之臨床試驗案外，尚包含在美國及日本送件及收案之研究案件。
