[徵才] Clinical Pharmacokinetic Specialist

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【職缺名稱】Clinical Pharmacokinetic Specialist 【徵才單位】IMC精隼企管顧問公司代徵(某外商CRO公司職缺) 【工作地址】台北市中正區【工作內容】 Job description: ‧Under supervision of a Clinical Research Services Director ‧To investigate clinical PK、BA/BE and PK/PD aspects of compounds in clinical development. ‧To design clinical PK Phase I studies、BA/BE studies; to provide PK sections for clinical study protocols of BA/BE clinical studies. ‧To coordinate actions to ensure timely delivery of protocols, execution, PK analysis and reporting of Phase I study and BA/BE studies within and outside the department. ‧To establish and maintain strong working relationships with other departments in an international environment (i.e. Clinical Operations, Global Strategic Outsourcing, Bioanalytics, Data management, Biostatistics, Medical Writing, Project physicians, and regulatory). ‧To perform and/or review PK、BA/BE and PK/PD analyses and population PK analyses and PK study reports and preparing scientific PK documents and reviews for regulatory submission. ‧To communicate and present clinical pharmacokinetic strategies, plans and PK study results to the projects teams, external audiences and regulatory authorities and to provide PK 、BA/BE and PK/PD expertise, as requested. ‧To work in an international environment. ‧To conduct other works which are assigned by management. 【徵才條件】 ‧Sufficient experience in PK 、BA/BE study and a good understanding in PK/PD modeling and applied statistics ‧Experience in the pharmaceutical industry and/or regulatory environment is an added value ‧Ability to work in a flexible way with different multidisciplinary teams, meeting deadlines ‧Strong communication skills, both verbal and written (English) ‧An analytical/scientific mind, creativity and innovation are key ‧Willingness to travel dependent on the project activities ‧Minimum of 1 year relevant experience gained within the pharmaceutical industry and / or within a CRO ‧Be familiar with WinNonlin. 【薪資待遇】面議(薪優) 【聯絡方式】請將履歷寄到 jerry.chiang@jobnet.com.tw 江先生 -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 118.170.121.146 ※ 文章網址: http://www.ptt.cc/bbs/Bio-Job/M.1411553356.A.E33.html