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1年经验 -
硕士 -
招2人 -
02-22 发布
- 五险一金
- 补充医疗保险
- 专业培训
- 年终奖金
- 弹性工作
- 定期体检
- 通讯补贴
- 餐饮补贴
- 交通补贴
职位描述
Line Superior---- Director of BE dept.Peer position---- Medical writer/Medical science Subordinate---- NA Deputy of responsibility---- Medical writer Scope of responsibility：Protocol Design/Synopsis Writing. Clinical Interim / Final Reports, PK/BABE Reports Statistical Analysis Report Conclusions Currently, this position will focus on early phase studies, such as pk/BABE studyResponsibility：1. To support BD team and provide expertise to clients for clinical studies.2. Paper research and IB writing/review. 3. Prepare bioequivalence study synopsis, protocol, report.4. Interpret and write clinical study reports. 5. Direct and provide technical and operational support to the activities of the medical writing staff and associated projects.6. Revise all kinds of documents and SOPs. Comply with company and departmental policies, guidelines, principles and procedures. Qualification (Basic)1. Master degree in Life Science or above 2. At least 2 years working experience, including 1 years of relevant industry (CRO/Pharmaceuticals) 3. Solid understanding of the principles of drug discovery and development 4. Broad protocol knowledge 5. Familiar with PK/BA/BE and Phase 1 study 6. Strong knowledge in pharmacokinetic study 7. Expert communication and presentation skills8. Have experience in pk study or formulation development is preferred.Qualification (Priority) Familiar to BE study will be plus. Ideally, the candidate will also have experience in formulation development. It would be helpful to discuss formulation improvement with pharmaceutical companies (sponsors). 职能类别： 临床研究员 生物工程/生物制药 关键字： 项目经理 PM Project Manager
联系方式
黄陂南路（地址1号线新天地站，9、10、13号线马当路站）
公司信息
PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。
