諾佛葛生技顧問股份有限公司

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2000 Số nhân viên
台北市中山區中山北路二段42號10樓B區
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Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk. Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives. Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary carers, and regular training, learning, and international knowledge-sharing opportunities.

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Phase I – III and VI Novotech’s registration clinical trials services are designed specifically for the sponsor with no local presence in the countries in which we operate. Our turnkey solution means all facets of a trial are covered by the one contract, including third party vendor management and local site agreements. Specifically the services provided by Novotech include the following: • Feasibility assessment and site selection • All IRB and regulatory approvals required to conduct a trial • Study management and monitoring for Phase I-IV studies • Third party vendor management • Local sponsorship • Full biometrics services, including randomisation and IWRS services • Medical and CSR writing

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Quy định pháp luật
1. 休假制度:第一年15天年假 2. 薪資制度:年薪14個月 3. 禮金加給:三節禮金、生育津貼、尾牙 4. 健康檢查:提供年度健康檢查,可依需求增減額度並提供親屬健檢優惠方案 5. 員工訓練:多樣化的線上線下訓練系統與課程、舉辦臨床試驗產業產業新知講座 6. 交通便利:彈性工時、位於中山商圈/南港生技園區 7. 其他福利:提供免費咖啡以及茶點、長期服務獎等 8. 國際交換和relocate program

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Cơ hội việc làm

Lab Manager/Associate Director/Director_Large Molecule 諾佛葛生技顧問股份有限公司
Thỏa thuận
台北市南港區
5年以上
Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.
Toàn thời gian
Cấp Quản lý/Giám đốc
Công việc không hoàn toàn online
10/18 Cập nhật
Researcher/Scientist_Lab-Large Molecule 諾佛葛生技顧問股份有限公司
Lương hàng tháng NT$ 50,000~75,000
台北市南港區
3年以上
The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.
Toàn thời gian
Cấp nhân viên cao cấp
10/18 Cập nhật