***企業徵才訊息***
台灣雙健維康生技顧問有限公司徵
《Medical Writer、Data Management Associate》
* Medical Writer
<工作內容>
1.Creating the documentation that regulatory agencies require in the approval process for medical product including drugs, devices and biologics. The documentation includes clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary and report documents in Common Technical Document [CTD] format.
2.Response to comments from health authorities and institutional review board
3.Creating documentations for data and safety monitoring board (DSMB)
4.Medical coding
5.Medical and scientific literature search
6.Creating other documentation relevant to clinical trials
<條件要求>
接受身份：上班族
工作經歷：1年以上
學歷要求：博士
科系要求：其他醫藥衛生相關、藥學相關、醫學系相關
語文條件：英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
擅長工具：Excel、PowerPoint、Word
工作技能：不拘
其他條件：極佳之英文寫作能力及醫藥專業
詳細職缺訊息：https://www.104.com.tw/job/?jobno=5cjbe&jobsource=
* Data Management Associate
<工作內容>
DM procedures:
1. CRF design
2. Data Management Plan (DMP) writing
3. Database set up
4. Data validation rule (DVP) writing
5. Data cleaning
<條件要求>
接受身份：上班族、應屆畢業生
工作經歷：1年以上
學歷要求：碩士
科系要求：醫藥衛生學科類、數學及電算機科學學科類、農林漁牧學科類
語文條件：英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
擅長工具：MS SQL、C#、R、VBA、SAS、Access、Database Management、JavaScript、HTML
工作技能：不拘
其他條件：
1. Proficiency of SAS programming or other programming skill
(such as R, C#, Javascript) is preferred
2. Familiar with statistical methods is a plus
3. Excellent organization skills and effective problem solving skills
4. Two years of relevant work experience is a plus
5. Experience with the EDC set up is a plus, such as Medidata Rave, DSG eCaseLink, Viedoc
詳細職缺訊息：https://www.104.com.tw/job/?jobno=4ecd7&jobsource=
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