PK Specialist药代动力学研究员
方达医药技术有限公司ShanghaiUpdate time: August 10,2019
Job Description
Responsibilities:
1. Analyze pharmacokinetic data using noncompartmental analysis, ensure quality and timely delivery of the project PK deliverables to Frontage clients. Assist with the implementation of quality control (QC) assessment and procedures, as well as scientific review.
使用非房室模型分析PK数据,确保PK项目能保质保量的按时交付给客户。协助实施QC评估和流程,以及技术审阅。
2. Write bioequivalence report independently with proficiency and contribute to other clinical pharmacology report for regulatory submission.
能够独立撰写生物等效性报告以及向监管机构提交的其他临床药理学报告。
3. As a PK scientist, develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, and listings and figures for bioequivalence and other early phase clinical pharmacology studies.
作为一个PK研究员,需要制定/审核方案、统计分析计划、PK/PD分析、PK / PD表格和图表,用以支持生物等效性和其他早期临床药理学研究。
4. Consult and interact with clients, other Frontage divisions, and third-party vendors.
与客户、方达其他部门、以及第三方供应商进行交流互动。
5. Maintain awareness of overall developments in the field of bioequivalence study and relevant clinical pharmacology and policies from regulatory agency (cFDA).
对生物研究领域的整体发展和相关临床药理学监管机构的政策有一定的意识
Qualifications:
1. PhD, MS or educational equivalent in Pharmacokinetics, Pharmaceutics, Pharmacology or related field,with minimum 1 year experience including pharmacokinetics, PhD (1 year) Masters Degree with 2 years of experience in pharmaceutical industry or CRO experience; or equivalent combination of education, training and experience. Under special circumstances, fresh graduate with practice experience may be considered.
硕士以上学历,药动学、药剂学、药理学相关专业。博士(1年),硕士 (2年)的制药行业经验或CRO工作经验,或具有同等教育、培训和工作经验。特殊情况下,有实际经验的应届毕业生亦可考虑。
2. Sound knowledge of Pharmacokinetic concepts, including noncompartmental and compartmental analysis as required.
懂得药代动力学知识,包括非房室分析和房室分析(Winnolin).
3. English writing proficiency is highly preferred.
英语写作熟练者优先考虑。
1. Analyze pharmacokinetic data using noncompartmental analysis, ensure quality and timely delivery of the project PK deliverables to Frontage clients. Assist with the implementation of quality control (QC) assessment and procedures, as well as scientific review.
使用非房室模型分析PK数据,确保PK项目能保质保量的按时交付给客户。协助实施QC评估和流程,以及技术审阅。
2. Write bioequivalence report independently with proficiency and contribute to other clinical pharmacology report for regulatory submission.
能够独立撰写生物等效性报告以及向监管机构提交的其他临床药理学报告。
3. As a PK scientist, develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, and listings and figures for bioequivalence and other early phase clinical pharmacology studies.
作为一个PK研究员,需要制定/审核方案、统计分析计划、PK/PD分析、PK / PD表格和图表,用以支持生物等效性和其他早期临床药理学研究。
4. Consult and interact with clients, other Frontage divisions, and third-party vendors.
与客户、方达其他部门、以及第三方供应商进行交流互动。
5. Maintain awareness of overall developments in the field of bioequivalence study and relevant clinical pharmacology and policies from regulatory agency (cFDA).
对生物研究领域的整体发展和相关临床药理学监管机构的政策有一定的意识
Qualifications:
1. PhD, MS or educational equivalent in Pharmacokinetics, Pharmaceutics, Pharmacology or related field,with minimum 1 year experience including pharmacokinetics, PhD (1 year) Masters Degree with 2 years of experience in pharmaceutical industry or CRO experience; or equivalent combination of education, training and experience. Under special circumstances, fresh graduate with practice experience may be considered.
硕士以上学历,药动学、药剂学、药理学相关专业。博士(1年),硕士 (2年)的制药行业经验或CRO工作经验,或具有同等教育、培训和工作经验。特殊情况下,有实际经验的应届毕业生亦可考虑。
2. Sound knowledge of Pharmacokinetic concepts, including noncompartmental and compartmental analysis as required.
懂得药代动力学知识,包括非房室分析和房室分析(Winnolin).
3. English writing proficiency is highly preferred.
英语写作熟练者优先考虑。
职能类别:医药技术研发人员
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上班地址:张江高科技园区李冰路67弄13号
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