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            400-885-9898
            更新于 4月7日
            智聯APPAPP
            舉報
            Clinical Assay Lead-上海（Contract ）
            2-2.8萬
            • 上海長寧區
            • 3-5年
            • 碩士
            • 全職
            • 招999人
            雇員點評標簽
            • 同事很nice
            • 工作環境好
            • 團隊執行強
            • 人際關系好
            • 氛圍活躍
            • 管理人性化
            • 實力大公司
            • 交通便利
            職位描述
            藥理研究
             崗位職責:
             1、Serves as a member of the clinical study team and analytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
             2、Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
             3、Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
             4、Contributes to the development of Best Practices, processes, templates, and policies.
             5、Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices.
             任職要求:
             1、碩士學歷，醫藥專業；
             2、要有大分子，小分析的經驗；
             3、英語聽說讀寫流利。
            工作地點
            長寧區上海中山西路999號華聞國際大廈16樓
             
             
            職位發布者
            程紅/招聘
            剛剛活躍
            立即溝通 
            公司Logo泰格醫藥公司標簽
            泰格醫藥(股票代碼:300347.SZ/3347.HK)是行業領先的一體化生物醫藥研發服務平臺，為全球制藥和醫療器械行業提供跨越全周期的臨床研究創新解決方案。通過全面的服務體系和頂尖的質量標準，我們助力生物醫藥產業提升研發效率、降低研發風險，確保研究項目高質量交付，加速醫藥產品市場化進程，履行對行業和患者的承諾。同時，我們也通過覆蓋各領域的 100多家子公司，打造賦能全產業鏈的創新生態，推動醫療產業創新和發展。作為全球化的研發平臺，泰格醫藥在全球布局 180多個辦事處和分支機構，擁有超過 9500人的專業團隊，覆蓋5大洲的 54個國家，致力于解決最具挑戰的全球健康問題，滿足患者的未盡醫療需求，創造社會價值，造福人類健康。更多詳情請登錄：http://tigermed.zhiye.com/或將您的簡歷發送至：TA@tigermedgrp.com（請務必在郵件主題中注明：意向地區+意向崗位+姓名）
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