「臨床試驗-醫藥學術專員 (Medical writer/Medical affairs specialist)」的相似工作

1.學名藥與新藥臨床一期試驗設計、計畫書撰寫、藥物動力學數據運算、試驗報告撰寫 2.臨床前藥物動力學數據計算與分析，試驗報告撰寫 3.藥物學術文獻彙整評估 4.法規單位函詢與意見回覆 5.台灣/歐美臨床試驗法規 6.一年以上相關工作經驗優先

(合作廠商: 生華生物科技股份有限公司) 公司以臨床開發為主、基礎研究為輔，致力於小分子抗癌新藥的研發，專注在「市場首見(first in class)」抗癌新藥開發，在資金、營運、智財、藥物合成、藥物製劑、動物試驗及臨床試驗等等管理之經驗豐富，隨著臨床試驗由一期進入第二期及三期，以及開發新的適應症應用，整合完備的資源，能提供合宜的培訓需求。 JD職缺說明: 職稱: 臨床前研究實習 • 具有規劃、管理及執行臨床前試驗/或是臨床試驗之能力。 • 具備基本分子生物實驗技術。 • 了解如何設計良好及合適的動物試驗，以充分了解試驗藥物的潛在風險和益處。

1. 執行臨床試驗相關業務，包含試驗前準備、臨床收案、受試者追蹤，及試驗資料管理等； 2. 協助研究倫理委員會送審、管理臨床研究資料； 3. 協助計畫相關行政作業，例如計畫審查作業等； 4. 其他研究主持人交代事宜。

CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP 3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports 4.regular report to sponsor/communication between sponsor and site. 5.site close-out/trial materials retrieval 6.audits/regulatory inspection participation upon request

1.協助執行臨床試驗專案管理的書面作業及文書處理。 2.與試驗團隊溝通試驗操作事宜，協助解決問題，確保專案順利推進。 3.設計、準備與管理試驗相關文件，確保文件品質符合規範。 4.協助試驗報告的撰寫、遞交與通報審查單位。 5.處理試驗專案的行政庶務工作。 6.完成主管交辦的其他任務。 7.CRA工作經驗二年以上。

執行試驗起始活動、試驗合約與經費協調、試驗文件與工具管理、試驗監測訪視、參與試驗各式會議、試驗進度追蹤與管理、執行試驗關閉訪視、協助試驗稽核與查核等等。

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion. 1.. Study Oversight & Compliance - Lead planning, execution, and management of clinical studies. - Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs. - Act as the primary point of contact for all clinical trial operational activities. 2.. Team Leadership & Coordination - Manage day-to-day activities of the clinical operations team. - Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met. 3.. Cross-Functional Collaboration - Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams. - Ensure efficient and effective study conduct through cross-functional alignment. 4.. Stakeholder Communication - Communicate study progress to internal and external stakeholders. - Identify and mitigate study risks and issues proactively. 5.. Site & Vendor Management - Oversee investigational sites and third-party vendors to ensure high-quality execution. 6.. Documentation & Systems - Ensure clinical project-related documents and systems are developed and maintained to high standards.

- 負責產品取證與國際法規申請（TFDA、FDA、CE） - 協助撰寫醫療軟體/AI產品相關法規文件 - 協助追蹤各國醫療法規與送審資料準備 - Handle certifications (TFDA, FDA, CE, etc.) - Prepare regulatory documentation for software/AI medical devices - Track global regulations and support submission

1. 職責與職位要求： *審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準 *與內部團隊協調，確保產品的合規性和註冊進度 *熟悉各國監管要求，確保提交的文件遵守各地的法規 *參與審查過程中的跨部門協作，確保項目的有效執行 2. 資格與技能要求： *具藥學、化學或相關領域背景 *至少有1年以上的藥品審查經驗 *了解國際藥品監管要求，包括ICH、FDA、EMA等 *強大的問題解決和溝通能力，能夠應對複雜的監管挑戰與協調合作 *英語口語和書面表達能力佳

AIBEDA is a Contract Research Organisation (CRO) specialising in medtech and AI-powered healthtech innovation. The company provides end-to-end services, including regulatory strategy, clinical protocol design, technology assessment, and market entry support, to help clients navigate the global regulatory landscape. With a focus on agility, data-driven insights, and global connectivity, AIBEDA transforms complex regulatory challenges into commercial success. Are you passionate about clinical research? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

1. Assist the clinical team in the preparation and distribution of administrative matters and clinical trial materials. 2. Assists the clinical team in filing and archiving clinical documents and reports according to scope of instructions. 3. PK sample logistics management, material ordering and preparation, distribution to sites, and contact with logistics for sample delivery. 4. Complete other tasks or assignments requested by Supervisor.

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.

【認識我們公司】 台田藥品股份有限公司成立於1987年，與台灣田邊製藥股份有限公司隸屬同一集團，是國內知名的日系藥廠，秉持著不斷努力、不斷進步的精神於2023年突破25億營業額，期望為面對疾病的所有人帶來希冀之選，為每一個人提供最適醫療方案的醫療管理企業。 主要產品包含但不限於生物製劑、心臟血管用藥、皮膚科用藥。 如果想瞭解更多關於公司資訊及產品介紹，歡迎至官網www.tanabe.com.tw瀏覽。 【工作主要內容】 1. 規劃並推廣指定產品之醫學策略 2. 持續蒐集並分析特定疾病領域之新知 3. 確認行銷活動正確推動、審查相關行銷素材 4. 協助新產品導入、擴充產品適應症或適用範疇 5. 評估候選產品的科學性與臨床應用性 6. 主管交辦事項 【建議具備的五大特質】 ✔ 良好的細節管理及分析能力 ✔ 良好的人際溝通能力 ✔ 良好的英文溝通能力 ✔ 具團隊合作精神，能跨部門完成共同專案 ✔ 願意接受挑戰和改變，以因應市場競爭及快速變動 【福利制度】 1.優於法令規定之休假制度 2.年終獎金及盈餘分紅 3.獎勵資深員工之久任獎金 4.健全的教育訓練制度 5.各項福利補助及措施 6.年度健康檢查及流感疫苗施打 7.守護員工健康之特約醫護諮詢 【面試方式】 二階段面試 第一階段將安排直接向共事主管進行面談，瞭解雙方需求，建議多提一些關於你想知道的問題，若初步有共事的想法，將安排第二階段深度面談。 如果對本公司經營理念、主要產品/服務項目、福利制度等，歡迎可到「公司介紹」頁面瀏覽。 如果看到這裡，希望加入我們一同努力，歡迎投遞履歷，並簡要說明想應徵的原因。

1.臨床試驗專案的主導、規劃、試驗進度追蹤管理、監督、回報及時程掌控。 2.管理臨床試驗相關費用與合約洽談、簽訂、付款、報帳、時程。 3.確保臨床試驗案符合GCP及相關各國法規。 4.領導跨部門團隊，協調與項目成員合作臨床試驗，案件執行管理等相關工作。 5.監督試驗過程與進度，確保所有步驟都符合GCP標準程序。 6.維護及協助臨床試驗相關文件記錄更新及管理，所有試驗文件檔案需整理並歸檔於部門內TMF。 7.其他臨床試驗相關之主管交辦事項。 8.文獻查閱及數據整理。

研究領域： 肺癌分子轉移機制 工作地點：臺北榮總病理檢驗部 ※ 本職缺為國科會延攬博士後研究人員計畫，歡迎有志從事癌症研究之青年學者加入。 【研究主題】 本實驗室專注於肺癌轉移的分子機制，探討轉移相關基因、調控路徑及腫瘤微環境的影響，結合細胞與動物實驗，研究基因調控與轉錄後修飾機制。 【徵求條件】 (1) 國內外生物醫學相關科系博士畢業，具備分子生物學及癌症醫學相關知識與實驗技能。 (2) 英文能力佳，熟悉並具英文學術論文撰寫及投稿經驗。 (3) 具實驗室實務經驗尤佳，具細心與耐心及團隊精神。 (4) 擁有生物醫學、分子生物學、藥理學、癌症研究等相關領域之博士學位，熟悉細胞與分子生物學實驗操作，包含肺癌細胞功能實驗 (wound healing、transwell migration/invasion、3D spheroid assay等)、分子生物技術 (qPCR、western blot、RNA immunoprecipitation (RIP)、chromatin immunoprecipitation (ChIP)、luciferase reporter assay、Western blot等)、具備實驗動物操作經驗者優先，尤其熟悉肺癌小鼠模式建立（如 tail vein injection、orthotopic implantation等）者。 (5) 能獨立思考、善於團隊合作，並具良好英文閱讀與撰寫能力。

工作內容 1.Prepare and customize the Informed Consent Form. 2.Organize translation/verification of document required for clinical trial submission. 3.Planning the clinical trial submission timeline. 4.To be responsible for preparation of TFDA/IRB submission, including the comment reply until obtaining TFDA/IRB approval. 5.To be responsible for preparation of Interim report submission and Final report submission, including the comment reply until obtaining TFDA/IRB approval. 6.Apply for IP IL permit, infectious sample export permit, NCC application for 3C device import/export. 7.Good communication with study team, manage TFDA officer and IRB staff to meet the submission timeline, and propose the resolution to the client 8. Planning the clinical contract budget and negotiate with site clinical research center to fast the CTAg execution. 9. Familiar with TFDA/IRB requirements to support the team and answer the regulatory questions from the client. ＊無經驗可，公司會進行工作技能相關訓練課程。 ＊有實際做過TFDA /IRB送審工作，且兩年以上工作經驗者優先錄取，待遇從優。

探索未來醫美奇妙之旅！我們正在招募充滿活力、富有創造力的夥伴，如果你對透過研究與實作來推動世界進步而充滿著熱情，渴望在一個充滿活力和機會的工作環境中發展自己，那麼這個機會絕對適合你！ 捷立康生技自許是一間成長型新創公司，使命感驅動著我們用創意與發明推動醫美產業進步。在人才招募時除技術素養外，更看重的是你／你 自身的價值：團隊溝通與共識合作、自發性能力、積極型的解決問題、可以改變也相信改變！ 我們的團隊就像一個大家庭，我們相信每個人都有獨特的才華和貢獻，期待著你的加入，一起共同探索BioMaterials未來醫美-AI科技領域！ 在這裡，你可以將想法化為實際的產品；你/妳的反饋也不止是一句留言；也可能是觸發下一代新產品誕生的關鍵。歡迎應屆畢業生或充滿實作精神的你，業師與協力廠協同落實商品化。 【我們提供的機會與資源】 ◉ 與跨國法規顧問及臨床機構合作，累積國際醫療器材註冊實務經驗（如 TFDA、FDA 510(k)、CE MDR、ASEAN、日韓等）。 ◉ 參與公司核心產品開發流程，提供合規建議，扮演從「開發到上市」的法規關鍵角色。 ◉ 建立並運作符合 ISO 13485、QMS 的品質系統，累積完整品質與合規系統操作經驗。 ◉ 提供內部專業訓練資源與外部進修支持，協助同仁持續精進醫材法規與國際認證知識。 【你的挑戰與發展】 ◉ 規劃並執行多國醫療器材註冊，管理許可證生命週期（初次申請、展延、變更、撤案等）。 ◉ 撰寫與維護 STED、CER、IFU 等核心法規文件，並協助產品標示、廣告宣稱等合規審查。 ◉ 協助內外部稽核與矯正預防措施（CAPA）、上市後監控（PMS）、不良事件及召回管理。 ◉ 回應國內外廠商或代理商對法規要求的專業問題，並整合跨部門資源解決實務挑戰。 ◉ 管理專案進度，協調研發、品質、生產、行銷等團隊達成法規送審及專案目標。

1. 產品技術支援、客訴案件處理 2. 產品行銷規劃執行 3. 產品教育訓練 4. 參展活動安排及規劃 5. 協助公司業務推廣 6. 主管交辦事宜或部門後勤支援

• Perform regular site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the Project Manager or Clinical Research Manager, as appropriate. • Perform feasibility study survey to identify the potential sites or strong the business opportunity. • Prepare and submit respective visit report in a timely manner after every site visit. • Communicate with investigators to obtain necessary documentation and information before, during and after the study on an ongoing basis, to met quality requirements of central and investigator site files. • Support RA team by collecting investigator site regulatory documents for regulatory and ethics committee/IRB submissions. • If appropriate, assist in generation of Clinical Trial Agreements according to standard and local country practices, and assist the sites in agreement completion prior site initiation. • Initiate investigational sites to ensure that they have a complete understanding of the clinical protocol and that they could abide by their obligations to conduct a clinical trial as required by applicable regulations.