迪哲医药

迪哲医药

迪哲医药（股票代码：688192）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了六款具备全球竞争力的产品管线，其中两大处于全球关键性临床试验阶段的领先产品，均已在中国获批上市。

公司网址：http://www.dizalpharma.com/

投递方式：staffing.hr@dizalpharma.com

联系电话：021-61097800

校园招聘招聘简章:

职位：原料药合成工艺（助理）科学家Process Development（Associate）Scientist

部门：Chemistry, Manufacturing and Control–Synthesis Innovation合成创新部

专业：Organic chemistryrelated有机化学及药学相关专业

学历：Master, Ph.D degree硕士/博士研究生

地点：Wuxi无锡

人数：3人

This role is todoprocess development and optimization for CMC development of early phase drug substance to achieve on-timedelivery of materialsandcost competitive synthesis,scale up manufacture, as well as writing synthesis/process related documents.

Responsibility:

·PerformAPI/RSM/SMmanufactureprocess development in synthetic lab, and scale up in kilo-lab,toachieve on-time deliveryforearly phase projects includingpre-clinicalandclinicalbatches.

·Drive process developmentfor robustness, cost competitiveness, lead-time control, and full compliance.

·Comply all EHS requirements,and timely communicate with EHS and other relevant team toimprove lab efficiency.

·Communicate and align with analytical,DP and APIgroup, CMC-RA, QA, and finance & procurement.

·Support the drafting and compilation of HA filing package, annual report, and various communication package per project needs.

Requirement:

·A Ph.D.or masterdegree in organic chemistryrelated, and interested in process development in small molecule API within pharmaceutical industry.

职位：药物分析助理科学家CMC Analytical Associate Scientist

部门：Quality, ARD and CMCRA- Analytical药物分析部

专业：Analytical Chemistry, Pharmaceutical Science, or related Discipline分析化学、药学或相关专业

学历：Bachelor, Master degree本科、硕士研究生

地点：Shanghai, Wuxi上海，无锡

人数：5人

This role is to perform analytical activities of R&D and commercial phase for drug substances or drug products including planning and performing analytical method development, validation and analysis for raw material, in-process control samples, intermediates, and final products, as well as writing or reviewing analytical documents under supervision of Sr. Scientist or Scientist.

在科学家或资深科学家的指导下，该角色负责研发和商业化阶段原料药或制剂有关的分析活动，包括规划和执行分析方法开发和验证，原料、中控样品、中间体和最终产品分析，以及撰写或审核分析文件。

Responsibility:

·Assist Scientist or Sr. Scientist to lead analytical activities for drug substance or drug product development of assigned projects to ensure their completion with high quality and on time.

帮助科学家或资深科学家负责项目的原料药或制剂研发有关的分析活动,确保高质量、按时完成分析工作。

·Perform development, validation, verification, and transfer of analytical methods of R&D and commercial phase for the analysis of raw material, in-process control samples, intermediates, final products, and cleaning verification samples.

执行原料、中控样品、中间体、最终产品以及清洁验证样品研发和商业化阶段所用分析方法的开发、验证、确认和转移。

·Lead stability studies, including all components of investigational and commercial medicinal products.

负责稳定性研究，包括临床试验用药品和已上市商业化产品。

·Perform and review analysis of raw material, in-process control samples, intermediates, final products, and cleaning verification samples.

执行和审核原料、中控样品、中间体、最终产品和清洁验证样品的分析工作。

·Write or review technical reports and CMC analytical section regulatory submission and response.

撰写或审核技术报告和CMC分析部分注册资料和回复。

·Contribute to the establishment of department SOP and work instructions.

协助制订部门SOP和工作指南。

·Ensure all lab processes are adhering to relevant regulatory GMPs and company policies and SOPs.

确保所有实验室流程符合相关GMP法规、公司政策和SOP。

·Supervise and manage the quality control activities and laboratory processes of the contract manufacturer/contract laboratory, and implement the review or approval of documents/records to ensure their compliance with GMP specifications and data reliability.

监督管理合同生产方/合同实验室的质量控制活动和实验室流程，执行文件/记录的审核或批准，确保其符合GMP规范和数据可靠性。

·Work collaboratively with CRO/CDMO, QA, other CMC functions to drive continuous improvement.

持续改进与CRO/CDMO，QA和其他CMC部门的合作。

·Monitor ARD KPIs and drive improvements.

关注并推动改进ARD绩效指标

Requirement:

·Effective oral and written communication skills in both English and Chinese and ability to appropriately communicate information to cross functional stakeholders and suppliers.

有效的中英文口头和书面沟通能力，能够与跨部门负责人和供应商进行合适的沟通。

·Knowledge of GMP, ICH, and safety guidelines.

熟悉GMP, ICH和安全指南。

·Solid knowledge of all laboratory equipment (e.g., HPLC, GC, KF, Titrator).

掌握所有实验室设备（如HPLC, GC, KF,滴定仪）。

·Strong problem-solving skills.

较强的解决问题的能力。

·Knowledge of statistical assessments of data.

熟悉数据统计分析知识。

·Proficiency in Microsoft Office Suite.

熟练使用微软Office办公软件。

·Experience of project management and writing laboratory SOPs.

有项目管理和撰写实验室SOP的经验。

·Willing to travel approximately 5 - 10%.

愿意出差大约5 - 10%。

职位：药物化学助理科学家Chemist – Associate Scientist

部门：Chemistry & Drug Safety- Chemistry药物化学部

专业：Pharmacy & Medical Related药学，医学相关专业

学历：Bachelor,Masterdegree本科，硕士研究生

地点：Wuxi无锡

人数：5人

Undertake day-to-day operations within the scientific Discipline. The Associate Scientist will display breadth and depth of technical knowledge and experience and will work with relative independency but still under direction and supervision.

Responsibility:

·Undertake daily lab operation work within the discipline as required.

·Execute experiments.

·Maintain clear records of experimental work.

·Act in accordance with all company policies on personnel, SHE, etc.

Requirement:

·Master degree or Bachelor degree in medical or pharmacy related major

·Good knowledge of clinical trial and GCP and regulatory requirement in terms of data management systems and activities

·Fluent English skill

·Proactive communication with others

·Can do attitude

·Open mind to learn new things

·Certificated SCDM is preferred

职位：Statistical Programmer Intern统计编程师实习生

部门：Clinical Development临床开发部

专业：Statistics, Mathematics, or related discipline统计学，数学等相关专业

学历：Master硕士研究生

地点：Shanghai上海

人数：3人

Learn the basic knowledge of pharmaceutical industry, CDISC standards and SAS/R programming, get familiar with the professional environment. Develop and/or implement SAS programs to produce or validation simple Tables, Listings and Graphs in clinical trials for Dizal products

Responsibility:

·Assist in statistical programming deliverables for one or more clinical studies

·Develop programs to produce simple tables, listings and graphs according to specifications

·Work with Infrastructure lead to develop programming apps or utility tools by using R or Python or SAS; or validate the apps or tools

Requirement:

·Basic knowledge of statistical and data processing software, e.g., SAS and/or R

·Knowledge of statistical concepts, such as p-values, rates and proportions, frequencies, confidence intervals, especially survival analysis.

·Good verbal and written communication skills

·Good attention to detail to ensure accuracy and reliability of results; builds and monitors quality in every work activity

·Proactive and motivated. Ability to learn

职位：临床监查培训生Clinical Research Associate Trainee

部门：Clinical Operations临床运营部

专业：Pharmacy & Medical Related药学，医学相关专业

学历：Master硕士研究生

地点：Shanghai, Beijing上海，北京

人数：2人

Participate in the coordination of and contribute to operational activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives during overall study management life cycle in country level.

Participate in CRA training program, if qualified after evaluation after LM, who will participate in site management as CRA role.

Responsibility:

1.Site management

•Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study team to ensure that quality commitments are achieved in a timely and efficient manner.

•Conduct site feasibility assessment.

•Contribute to the selection of potential investigators and leading investigator.

•Contribute to national Investigator meeting.

•Obtain and maintain essential documentation in compliance with international guidelines ICH-GCP, Company procedural documents and local regulations both in the office and at site.

•Actively participate in local Study Team meetings. Share information on patient recruitment and study site progress within local Study Team. Good knowledge in relevant Therapeutic area to train, support and advice Investigators and site staff in study related matters.

•Initiate monitor and close study sites in compliance with Company procedural Documents. Ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.

•Drive performance at the sites.

•Update study related systems with data from sites per required timelines.

•Manage study supplies, drug supplies and drug accountability at study sites.

•Perform source data verification. Proactively identify study-related issues and escalates as appropriate.

•Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.

•Ensure accurate and timely reporting of Serious Adverse Events.

•Work with data management to ensure quality of the study data. Ensure data query resolution.

•Prepare for activities associated with audit and regulatory inspection at responsible sites and/country in liaison with local study team lead and QA.

•Responsible for completeness and timeliness of the eTMF to maintain it “Inspection Ready”.

•Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent especially when it’s related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients' rights and wellbeing.

2.Management and Relationship Responsibilities

•Provide clear guidelines and share information with investigators on study objectives and procedures to build their understanding of expectations and targets.

•Motivate and support investigators and site staff to achieve target patient recruitment, identifying issues and liaising with site staff to develop solutions.

•Set up the close connection with KOLs and field thought leaders, maintain the good relationship with the cooperated sites.

Requirement:

•Good medical knowledge and basic understanding of the drug development process.

•Fluent knowledge of spoken, read and written English.

•Team oriented and flexible. Ability to manage & prioritize multiple tasks with conflicting deadlines ability to work in an environment of remote collaborators

•Meticulous and detail-oriented

•Ability to travel nationally as required.

职位：医药代表实习生Sales Intern

部门：Commercial商业化团队

专业：Pharmacy,Medicaland Life ScienceRelated医药，及生命科学相关专业

学历：Bachelorandabove本科及以上

地点：China全国

人数：100+人

主要职责：

·执行公司市场部产品推广计划和方案，完成及超越公司的销售指标；

·熟练掌握公司及产品，并且相关领域疾病、竞品知识，熟练并能独立组织幻灯演讲，向医学专业人士传递正确的产品信息或者最新医、药学资讯；

·有效的将目标客户进行分级管理，合理安排拜访频率，传递正确的产品信息；

·相关数据的及时维护和更新，准确并及时的反馈市场信息

·协助主管完成招标和医保相关事务

任职资格：

·有很高的从事医药销售推广意愿；

·较强的业务敏锐度，解决问题的能力，客户沟通能力，有较强的观察、学习与运用能力，很好的执行力

·不畏艰难与挑战，坚持不懈的追求成功与卓越；

·良好的品格，坚决遵守国家和公司的相关法规、条例。

备注：需要参加专业实习培训，培训结束后通过考核予以录用

职位：医学事务实习生Medical Affairs Intern

部门：Commercial商业化团队

专业：Pharmacy,Medicaland Life ScienceRelated医药，及生命科学相关专业

学历：Bachelorandabove本科及以上

地点：Shanghai上海

人数：2人

主要职责：

·医学项目内部流程支持，如项目申请/审批/结算/材料整理等

·市场/活动信息收集及统计分析

·文献查阅及整理

任职要求：

·良好的英语读写能力

·excel技能熟练

·一周实习3天及以上，连续3个月或以上

职位：市场实习生Marketing Intern

部门：Commercial商业化团队

专业：Pharmacy,Medicaland Life ScienceRelated医药，及生命科学相关专业

学历：Bachelorandabove本科及以上

地点：Shanghai上海

人数：2人

主要职责

·市场项目内部流程支持，如项目申请/审批/结算/材料整理等

·市场/活动信息收集及统计分析

·文献查阅及整理

任职要求

·良好的英语读写能力

·excel技能熟练

·一周实习3天及以上，连续3个月或以上

职位：人力资源实习生HR Intern

部门：Human Resource人力资源部

专业：Law, English, JournalismRelated法学或英语或新闻等文科类专业优先

学历：Bachelorandabove本科及以上

地点：Shanghai上海

人数：2人

岗位职责：

•全国各地法规政策咨询和汇总，如社保公积金，个税政策，积分落户等

•协助校园及社会招聘简历筛选、面试安排、沟通协调

•人力资源日常数据整理、统计、测算及分析

•员工档案、培训档案整理归档及合同管理

•人力资源福利项目的支持和沟通材料的准备

•参与并协助雇主品牌及招聘相关活动

岗位要求：

•清晰的逻辑思维及表达能力

•有学习的热情以及快速适应环境能力

•有Excel（如V-lookup/数据透视表）、PPT或其他办公软件经验

•每周可实习3天以上，能够持续实习3个月以上，提供转正机会

职位：法务实习生Legal Intern

部门：Legal法务部

专业：Law, English, JournalismRelated法学或英语或新闻等文科类专业优先

学历：Bachelorandabove本科及以上

地点：Shanghai上海

人数：1人

主要职责：

·OA系统中文件的比对，审批和文件归档

任职要求：

·在校本科或硕士学生，法学或英语或新闻等文科类专业优先

·熟练使用word，英文读写良好

·每周可以实习3天。

职位：财务实习生Finance Intern

部门：Finance财务部

专业：Accounting会计专业

学历：Bachelorandabove本科及以上

地点：Shanghai上海

人数：1人

主要职责：

·负责日常费用报销的审核及在SAP系统中的记账工作。

·按照公司政策和当地法规及时、准确地执行会计活动，以验证和记录应付账款发票和费用报销。

·高效监控待处理发票的状态，并及时与当地实体沟通解决应付账款和支付问题。

·支持月末财务结账工作。

任职要求：

·本科及以上学历。

·会计专业背景并掌握会计基础知识。

·快速学习能力，逻辑思维和创造力。

·良好的沟通技巧，主动性和责任感，能在压力下工作。以客户服务为导向，团队合作精神。

·熟练使用微软软件，特别是Excel。

·熟悉SAP系统者优先。

·每周可到岗三天，可长期实习者优先。