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崗位職責：
1、負責非臨床藥代動力學研究方案設計，組織實施試驗開展，統(tǒng)籌協(xié)調內外部資源，確保項目按計劃推進，對整個試驗設計和實施過程的科學性負責；
2、負責撰寫、審閱、修訂試驗方案、數(shù)據(jù)、報告、IND/NDA申報資料及相關SOP等中、英文文件，確保研究的資料真實、準確、有效以及SOP文件的適用性；
3、支持與國內、外客戶及專家的技術與商務交流；
4、負責前沿技術內容與文獻調研、跟蹤監(jiān)管環(huán)境的變化、國內外相關指導原則的更新，支持內部業(yè)務能力的優(yōu)化提升；
5、完成上級領導安排的其他工作。
任職要求：
1、碩士及以上學歷，藥學、醫(yī)學、生物學相關專業(yè)，掌握藥物化學、藥物分析學、生物化學等學科的基本知識；擁有5年以上非臨床藥代動力學研究經(jīng)歷，具備豐富的國外客戶項目交付和技術交流經(jīng)驗，曾在海外CRO公司任職者優(yōu)先；
2、熟悉NMPA/FDA/EMA等相關藥代動力學研究指南與法規(guī)；
3、具有較強的文獻調研及匯總能力，有熟練的英語聽說讀寫能力，口語流利，能夠無障礙地進行跨國會議、技術研討和書面報告；
4、具備較強的學習與整合能力、溝通協(xié)調能力、團隊合作精神及責任心。
Duties & Responsibilities:
·Responsible for designing preclinical pharmacokinetic study protocols, organizing and implementing experiments, coordinating internal and external resources, ensuring projects proceed as planned, and taking responsibility for the scientific validity of the entire study design and implementation process.
·Responsible for writing, reviewing, and revising study protocols, data, reports, IND/NDA application materials, and relevant SOPs (both in Chinese and English), ensuring the authenticity, accuracy, and validity of research materials as well as the applicability of SOP documents.
·Support technical and business communications with domestic and international clients and experts.
·Responsible for researching cutting - edge technologies and literature, tracking changes in the regulatory environment, and updates to relevant domestic and international guidelines to support the optimization and improvement of internal business capabilities.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
·Master's degree or above in Pharmacy, Medicine, Biology or related disciplines, with a good command of basic knowledge in Pharmaceutical Chemistry, Pharmaceutical Analysis, Biochemistry and other subjects.
·At least 5 years of experience in non-clinical pharmacokinetics research, rich experience in overseas client project delivery and technical communication, and prior work experience in overseas CRO companies is preferred.
·Familiar with NMPA/FDA/EMA and other relevant pharmacokinetics research guidelines and regulations.
·Strong ability in literature research and summarization.
·Excellent written and oral communication skills in English as a must, conduct cross-border meetings, technical discussions and written reports without obstacles.
·Strong learning and integration abilities, communication and coordination skills, teamwork spirit and sense of responsibility.