1. 癌幹細胞、幹細胞及免疫細胞實驗操作及產品製程生產操作 2. 協助研究開發新產品及測試確效 3. 產品品管及檢驗 4. 協助收集和分析產品設計資料，研究產品發展趨勢，跟進行業動態及政策 5. 協助特管法、人體試驗、新產品行銷企畫案專業內容撰寫 6. 協助研發團隊的資源管理、人員調配和培訓 7. 支援公司其他事項及主管交辦事項
工業技術研究院 國際級的應用研究機構，擁有六千位研發尖兵，以科技研發，帶動產業發展，創造經濟價值，增進社會福祉為任務。 工研院產業科技國際策略發展所(簡稱:產科國際所) 是政府與產業均仰賴的智庫，結合產業研究與國際業務推動能量，以協助台灣產業布局全球市場為己任，以『促進台灣產業科技創新與價值提升』為願景。 旗下經營的IEK產業情報網已超過15年歷史，是國內產業情報資料庫的領導品牌。 IEK產業情報網：http://ieknet.iek.org.tw/ 工作內容: 因應醫療AI產業發展之產品驗證與保險給付之所需，負責擬定臨床實證醫學AI相關指南，協助建立台灣醫療AI發展基礎。 工作地點:台北生技園區(115台北市南港區忠孝東路七段508號) 歡迎您加入團隊，成為未來智慧醫療產業儲備領袖人才！
**試用期考核通過後之薪資4萬以上** (1) 產品推廣 (2) 產品客戶服務支援，教育訓練 (3) 產品評估與諮詢，疑難解決 (4) 儀器連線溝通測試 (5) 協助新產品之資料蒐集整理 (6) 主管或客戶之其他交辦事項
1. 執行內外部專案的技術轉移（Technology transfer），製程放大設計和規劃 2. 新產品導入風險評估 3. GMP 生產相關支援，如異常調查、變更管制、矯正及預防（CAPA）、試驗計畫/報告等文件撰寫與執行 4. 協作執行製程確效（PPQ）和持績製程確認（CPV） 5. 分析並統整跨專案之製程效能和產品品質數據 6. 製造廠之製造技術開發專案的主導與執行
【工作內容】 1.進行外泌體新藥與製程開發等相關試驗。 2.進行純化、配方等相關開發測試。 3.參與各項專案或研發實驗設計、進行與分析。 4.搜尋整理文獻。 5.協助行政事務處理。 6.其他主管交辦事項。
【工作內容】 1.細胞分子生物相關實驗 2.簡易小鼠實驗 3.訂購實驗耗材及管理實驗室帳務 4.協助執行科技部及院內研究計畫 5.協助完成成果報告整理及撰寫 6.協助行政業務及主管臨時交辦事項
• Represent clinical pharmacology for the assigned study team to support clinical study conduct from clinical pharmacology perspectives. • Translate nonclinical data to human efficacious dose projection. • Design experimental PK or PKPD studies in animal or human to better understand the clinical pharmacology of compound in development. • Conduct Non-Compartmental Analysis (NCA) for nonclinical and clinical PK studies and writing the PK reports. • Work with vendor or perform in-house population PK and PKPD analyses. • Responsible for preparation of regulatory submissions such as IND submission, and response to health authority’s questions with respect to clinical pharmacology.
【Study/ site management】 ※ Plans, executes and oversees clinical trials to ensure timely completion of the investigation, from study start-up, IRB/ regulatory submission, budget negotiation and agreement execution, to site management. ※ Manages sites by supporting IRB/ regulatory submissions (including amendment, annual renewal, safety reporting), conducting monitoring visits (including site qualification, initiation, monitoring and close-out) and keeping regular contacts to ensure trials are executed in accordance to protocol, SOP and other applicable requirements, and milestones are achieved. ※ Develops or provides input into the required clinical documents (such as project schedule, Clinical Investigational Plan, Patient Informed Consent, study budget/ contract, study training materials and study reports) in collaboration with investigators and the cross-functional study team to meet business needs. ※ Critically evaluates study progress and metrics. Collaborate with cross functional team (local and global) to identify risks and mitigation plans. 【Collaboration】 ※ Cultivates strong relationship with clinical investigators and site staff to ensure high quality in trial execution. ※ Collaborates with leadership to assure successful project delivery. ※ Interfaces with key functional areas in order to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement.) ※ Facilitates or leads project meetings including external health care professionals and internal (local and global) cross-functional stakeholders. 【Business acumen】 ※ Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes. ※ Evaluates clinical data/ evidence and may determine application of study results. May provide input and support for planning post-clinical activities, educational activities, and market launch of products ※ Supports other projects and duties, and participates in process improvement initiatives as requested by the Clinical Research Manager. 【Physical job requirements】 ※ Travels to field sites to supervise and coordinate clinical study activities, and attend oversea meetings. ※ Expects to have some out of hours and on-call work when required. 【Required skills】 o Tertiary education in medical/ biological/ science/ nursing or equivalent field o Experience in clinical research : 4-7 years, experience in medical device is an advantage, o Strong interpersonal, communication and negotiation skills o Problem solving, multi-tasking o Detail-oriented o Able to work independently and as a team o Proficient knowledge of clinical research study processes and study design; demonstrated ability to incorporate and adhere to Good Clinical Practices and local regulatory standards. Nice to have ISO 14155 knowledge. o Proficient knowledge in EDC, word processing, spreadsheets, database applications (e.g., Excel), and/ or PowerPoint.
Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
* 凡對新創公司、精準醫療、癌症研究等領域有興趣、有熱情的博士級人才，歡迎應徵申請。 工作內容： * 進行流程優化及撰寫技術文件。 * 內/外部研發計畫提案與執行。 * 科學報告撰寫與文獻/市場報告分析整理，並參與專業會議與研討會。 * 完成主管交辦事項。
1. Conduct presentations to clinicians, academia and other potential collaborators about the scientific principles and clinical applications of ACT Genomics’tests 2. KOL identification, prioritization and engagement 3. Identify and provide unbiased medical and scientific information to clinicians 4. Collect insights from the field, feedback to internal stakeholders and implement them into company’s medical affairs strategies 5. Conduct ongoing training for distribution partners, customers, and corporate colleagues including TW, HK, and SEA. 6. Understanding, comprehension and compliance to genetic testing guidelines in the region 7. Collaborate with the marketing and sales teams to develop and update supporting materials. 8. Address inquiries and requests related to clinical applications, leveraging in-depth knowledge of clinical data from conference, publications, and clinical trials. 9. Support organizing scientific and educational events 10. Able to travel 30-50% of time 11. The position may require the flexibility to work on evenings and weekends (field activities)
在Wellell，身為臨床研究員，您將負責協助公司執行產品臨床評估、臨床試驗、上市後追蹤…等研究計劃，並確保產品遵循醫療法規要求與標準，達到臨床效益並符合公司期待 [工作內容] 1.撰寫公司產品的臨床評估計劃及報告 2.設計臨床試驗計劃，申請IRB臨床許可，與醫院合作執行臨床試驗，完成研究報告的撰寫 3.規劃及執行上市後臨床追蹤活動 4.協同品牌行銷部門規劃及執行臨床行銷活動(如：醫學年會發表) 5.建立及經營醫療院所之專家顧問的關係，並與其合作評估產品的臨床性能 或執行臨床試驗 6.內部分享及教育訓練相關臨床知識 7.定期執行臨床文獻探索，找尋特定適應症相關未滿足需求
1. 臍帶血濃縮、凍存。 2. 免疫細胞濃縮、凍存。 3. 實驗室庶務維持。 4. 製程方法確校、優化與改良。 5. SOP文件撰寫、審閱與發行。 6. 完成主管交辦事項。
Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. One of FORTUNE’s ‘Most Admired Companies’, we offer unparalleled scope for a career in world-leading clinical research. Global projects, innovative tools and industry leading customers combine with outstanding support and clear career management which allows you to make a difference and to connect with great opportunities. While projects vary, your typical responsibilities might include: Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. - Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. - Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. - Collect information on team performance against contract, customer expectations, and project baselines. - Lead problem solving and resolution efforts to include management of risk, contingencies and issues. - Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. - Provide input for the development of proposals for new work and manage project budgets. - Provide input to line managers of their project team members’ performance relative to project tasks. - Prepare and present project information at internal and external meetings. - Participate in proposal development and in the bid-defense process with guidance and supervision. - Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally you will also have some global experience, and a pharmaceutical or CRO background.
1. Medical Writing： 撰寫醫藥行銷、病人衛教、醫學研究相關文件或製作物，包括醫學會議紀錄、醫學簡報、醫藥行銷文案、衛教資訊、診治指引、論文編修等 2. Medical Editing： 醫學文件／製作物的編輯和校對，包括作品的呈現方式、內容的正確性、表達的一致性等 3. Medical Communication： 對外與客戶溝通醫學文件或製作物內容，理解客戶需求並適時提供建議；對內與設計部門合作，討論醫學製作物的最佳呈現方式 4. Others： 出席醫學會議 ※履歷能檢附醫藥相關文字作品尤佳 ※了解業界行銷生態、製作物重點，中文文筆精準、柔順 ※樂意與團隊分享經驗，一同規劃提升醫學編輯技巧的方式
We are actively recruiting a highly motivated medical scientist to join our team and to contribute to non-clinical and clinical studies in current TWiB programs. The position offers an exciting opportunity for growth and development in the pharmaceutical and medical research field and will report directly to the Head of Medical Research. Title and compensation are commensurate with experience and qualifications. Responsibilities: 1. Collaborate with the research team and CROs to design, conduct and evaluate non-clinical studies to support regulatory filing. 2. Assist in the preparation of medical and regulatory documents for IND filing, regulatory submission, and publication. 3. Support Product Development to implement business development strategies. 4. Engage and communicate with KOLs, physicians, and patient advocacy groups to gather insights and feedback relevant to ongoing projects. 5. Provide essential administrative support, including organizing meetings, maintaining documentation, and coordinating logistical aspects of research activities.
1.負責國內醫療院所臨床癌症檢測相關分析服務。 2.預防醫學及精準醫療檢測研究開發。 ~視學經歷條件，核定職稱及薪資，歡迎優秀人才加入~
1. 初代細胞分離與培養 2. 細胞製劑開發相關研發 3. 細胞測定方法研發 4. 生化分生技術操作 5. 實驗數據分析 6. 專案進度控管與報告
1. 管理並支援臨床試驗中心的臨床護理師收案相關事宜，協助費用報支申請。 2. 控管臨床試驗中心藥品與經費狀況，維持案件持續執行。 3. 控管委外檢驗報告的進度，匯總檢驗數據，申請費用報支。 4. 管理官方文書，匯整更新臨床試驗相關文件。 5. 了解各國臨床法規，並執行公司後續產品臨床收案計畫。 6. 產品臨床法規、標準之蒐集/彙整更新及維護。