「生醫法規實習生」的相似工作

心臟節律器產品部門實習生 工作內容： 1. 協助接聽病友及家屬電話進行產品使用服務追蹤 2. 資料核對與輸入、文件整理與歸檔，並協助主管交辦之行政工作 需求條件: 1. 認真負責、細心、耐心溝通 2. 若為在校學生、夜間部就讀同學，可依據上課時間調整排班時間，但至少每週需至少上班24小時 3. 能持續合作至少一年以上佳 4. 需要條件: 台語溝通流暢

協助 GMP 文件管理作業（如：文件發行、歸檔、異動申請、電子系統資料維護等） 協助訓練管理系統資料維護（課程登錄、訓練紀錄整理、追蹤與彙整） 協助部門內部行政庶務（文書處理、表單整理、資料上傳等） 支援 QA 團隊相關 GMP Operation 文件與教育訓練事務 人格特質：細心謹慎、積極主動、具責任感、樂於學習與團隊合作。 上班地點：近捷運中山站6號出口 所屬部門：品質保證部（QA Department） 開放夜間部在學生或大專在學生工讀 薪資依工作時數與表現於面試時議定 大四應屆畢業生工讀期滿後可面談轉正

仁新醫藥股份有限公司正在尋找一位優秀的研發專員或是科學家(學士、碩士、或是博士級科學家)加入我們的研發團隊。此職缺將專注於新藥開發所需要的生化實驗以及細胞實驗等技術。此職缺需要總結實驗數據並能夠撰寫科學報告來解釋數據。此職位任職於我們在台北南港軟體園區的實驗室。 必要資格  化學、生物學、細胞生物學或相關學科的學士或碩士或博士學位  高度自我激勵和目標導向  具備靈活性的團隊合作夥伴，熱衷於溝通與內部及外部夥伴合作。  注意細節並有獨立設計實驗能力  在實驗室方面具有豐富經驗  在計劃、執行和分析實驗方面表現出卓越能力，英文能力能夠撰寫技術報告和內外溝通  能夠具有解決問題能力並改進實驗方法 ※本公司將評估該職務內容及個人學經歷從優核定給薪。

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

Main roles/responsibilities 1. Design, execute, and analyze experiments related to iPSC editing, differentiation, and characterization. 2. Identify, optimize, and implement novel strategies for differentiating iPSCs. 3. Write and revise standard operating procedures for iPSC differentiation processes. 4. Prepare and conduct experiments for the generation and analysis of iPSC-derived cells, including the preparation of reports and test methods 5. Ensure timely completion of experiments, data analysis, and tasks as assigned. 6. Analyze data, monitor assay quality, troubleshoot, and present findings to project teams and research organizations. 7. Demonstrate accountability and flexibility in adjusting project objectives based on evolving project needs. 8. Collaborate with cross-functional teams to align iPSC cell therapy strategies with the company’s goals and project objectives. 9. Contribute to the development and execution of strategic plans for iPSC-based therapeutic applications, ensuring alignment with evolving project requirements. 10. Adapt research plans and priorities based on data insights, project milestones, and the company’s changing strategy. 11. Provide scientific guidance and adjust protocols as needed to meet dynamic project timelines and goals. Job Requirements 1. Ph.D. in Stem Cell Biology, Molecular Biology, Development, Immunology, Biochemistry, or related fields, with at least 2 years of industry experience. 2. Extensive laboratory experience in designing and conducting experiments, demonstrating strong problem-solving skills. 3. In-depth understanding of cell biology, molecular biology, cell therapy, and principles of cellular immunotherapy. 4. Proficient in molecular biology and cell biology techniques, including mammalian cell culture, flow cytometry, immunolabeling, ddPCR, and genomic analysis. 5. Willingness to work on weekends for iPSC cell culture and participate in rotating duty schedules. 6. Self-motivated, detail-oriented, and able to multitask effectively in a fast-paced, collaborative environment. 7. Strong independent thinking, troubleshooting skills, and excellent communication and teamwork abilities. 8. Strategic mindset with the ability to adapt research priorities to align with evolving project and company needs. 9. Demonstrated flexibility and problem-solving capabilities in responding to changes in project direction, timelines, and requirements. Technical/Skills Required 1. Commitment to continuous learning and acquiring new knowledge to meet job requirements. 2. Strong professionalism, ethical standards, and a sense of responsibility. 3. Ability to work under pressure and manage multiple tasks efficiently. 4. Self-motivated, hands-on, disciplined, detail-oriented, and proactive, with a strong team spirit. 5. Strategic thinking with the ability to adapt to shifting project demands and therapeutic goals. 6. Ability to balance scientific rigor with business objectives, aligning research strategies with company goals. 7. Flexibility in adopting new approaches and optimizing processes based on evolving scientific insights and market needs.

1.審視所屬產品線之內外部競爭環境，訂定全產品線年度業績標及策略，所訂定之目標需符合公司預算標準。所設計之行銷計畫須與GM的業務目標一致並經公司管理層檢視及同意。 2.注重高績效文化，以客戶為導向，以數據分析為基礎，推廣有效創新行銷策略，發展市場，並對結果負責。 3.維持與重要意見領的脈絡關係，經常性拜訪重點客戶，以確保行銷策略方向正確。經營相關學會及病友會，確保行銷策略之綜效。 4.與原廠(Chiesi/TaiMed)alliance、commercial team 及medical team維持正面且密切的合作以確保落地行銷策略與全球一致，已對公司有利的方式支持產品順利上市。 5.與公司內部各部門(BD、GOB、RA、Market Access、Medical、finance、HR)協作確保溝通無礙，產品查驗登記及健保策略之設定，並依審查過程可能遇到的挑戰提供必要協助，確保上市流程順暢。

此職務是連結研發與 GMP 生產的重要橋樑。您將不僅負責製程優化與放大，還需執行毒理批次 (Tox material) 生產，並承擔技術轉移 (Tech Transfer) 至 GMP 的任務。此角色同時涵蓋 MSAT (Manufacturing Science and Technology) 的核心功能，確保製程具備穩健性、可重現性與 GMP 導入準備。 1) Process Operations and Scale-Up - Manage and execute process operations ranging from 5 to 200 liters. - Ensure consistency, scalability, and reproducibility of upstream processes. 2) Tox Material Production - Lead the production of non-GMP toxicology batches to support preclinical studies. - Ensure materials meet quality standards and development timelines. 3) Process Optimization and DOE - Design and conduct experiments (DOE) to optimize upstream workflows. - Continuously improve existing processes for better yield, efficiency, and robustness. 4) Tech Transfer to CDMO - Prepare documentation and transfer processes to external CDMO partners. - Provide MSAT support to ensure smooth transition into GMP environments. 5) Cross-Functional Collaboration - Work closely with downstream, analytical, and quality teams to support integrated project needs. - Effectively communicate results and process improvements through reports and presentations. 6) Laboratory and Project Support - Assist in laboratory material management to ensure smooth operations. - Support other functional teams as needed to meet project goals.

〔工作內容〕 半導體封裝設備之業務銷售 (切割機/研磨機設備) *開發, 建立及維持與客戶的良好關係. *能熟悉社內產品細節並進行專業的中英文簡報. *能了解客戶半導體封裝製程細節及需求並提出解決方案. *能就客戶需求與公司內部其他部門進行資源協調. *能與業務主管一同制定業務方針並執行以達成業務目標. *協助進行各種市場及競爭公司資訊調查. *能與日本母公司之業務及工程人員以英文 (或日文) 進行直接的溝通. *具半導體相關工程背景者尤佳! 〔需求條件〕 - 具備設備業務工作相關經驗(對應過大客戶加分) - 需自備交通工具-普通小型車即可. - 需配合出差. - 語言條件: 英文中等以上, 會日文者更佳. 〔任用方式〕 正職錄用 〔工作地點〕 新竹縣湖口鄉 〔工作時間〕 週一至週五 08:30~17:30 週休二日 國定假日休假 〔薪資福利〕 依照學經歷背景核定 * 薪資福利制度說明: - 年薪12個月. - 夏季&冬季獎金共二個月(以全薪計算/需符合公司獎金規定). - 績效獎金(以全薪計算/需符合公司獎金規定).

"國際製藥大廠，穩定發展，正職獵才機會" 將支援公司品質保證與品質控制相關作業，工作橫跨實驗室操作、 品質系統管理、供應商與倉儲管控，是企業品質穩定運作的核心角色!!! ----------------------------------------------------------------------- * QC (分析部門/微生物部門) 需求:1-3人 1.進行原料及成品檢驗 2.儀器設備之校正與定期保養 3.樣品留樣與安定性試驗管理 4.檢驗方法修訂、撰寫 加分特質: 1.具藥廠檢驗及實務經驗尤佳 2.具備儀器校正與保養經驗尤佳 若您對品質把關有熱忱，並具備實驗室操作與紀律執行力， 這將是您在國際藥廠職涯邁進的重要一步！

本公司是專業的醫療器材法規顧問公司, 客戶為國外各大醫療器材製造廠 為配合公司業務發展, 徵求更多優秀人才 有醫療器材法規工作經驗, 尤其在產品查驗登記者佳 工作內容 : 醫療器材法規顧問 醫療器材技術文件及檢驗報告審查 醫療器材食藥署查驗登記送審, 並與審查員良好溝通聯繫 與國外醫療器材製造廠溝通聯繫 孰悉各國醫療器材檢驗標準 (FDA, ISO, IEC, ASTM)

1. 執行銷售策略，傳遞企業形象與產品價值，達成業績目標。 2. 執行客戶分級與區域管理，與主管共同設定客戶拜訪計畫並落實。 3. 確認主要客戶，執行區域內小型行銷活動，協助行銷部門執行大型行銷活動。 4. 收集市場資訊並回饋內部（如：招標訊息之傳遞給業務行政單位…等）。 5. 深入了解客戶與公司需求，有效處理區域內緊急事件。

• 操作基因檢測相關實驗 • 執行次世代定序（NGS）平台操作，進行樣本前處理、文庫建置與定序流程 • 進行生物資訊分析與數據整理，提供後續臨床風險評估 • 確保實驗流程符合實驗室品質系統標準（如ISO 15189） • 配合跨部門溝通與資料整合 • 撰寫與維護SOP文件，協助提升實驗室作業效率與準確度 • 支援主管交辦之其他技術開發或專案任務

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

1. 數位、類比信號PI/SI模擬及設計優化。 2. VNA、TDR、oscilloscope儀器量測及操作 。 3. 其他主管交辦事項。

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。

2025 B. Braun Internship Program - Marketing Intern (歡迎大四生與研究生二年級在校生，一週能上班三天) B. Braun' s Internship Program is designed to provide university-enrolled or recently graduated students with a meaningful experience within the medical device industry. The students are given an opportunity to gain a valuable corporate or manufacturing learning experience through a finite project determined by each department. Projects vary for each intern assignment depending on the needs of the department, and each will provide the intern with both a meaningful and relevant work experience. Internships are a 6 months commitment. An assigned mentor will help guide the intern through the experience. Interns will be asked to conduct a presentation to their department outlining their internship experience. Thank you for your interest in B. Braun Taiwan Internship Program. B. Braun internships are posted intermittently throughout the year. Please create a profile, upload your resume, and be ready to apply to an internship that interests you. We take talent very seriously, and the Company is updating its career website to provide you with an easy and engaging way to apply for a position with our team. If you would like to work for one of the B. Braun Group of Companies, please visit Facebook or youtube to take a step toward an exciting career. In this Role, you will provide a highly efficient support to Marketing team on timely manner. Tasks & Responsibility: • Assist with Administrative Tasks - Existing tasks such as placing orders with printing vendors for marketing material, e.g. patient booklet. - Demo goods delivery arrangements, including sending and receiving decoration items for events. - External communication with stakeholders • Assist with Maintenance and Coordination of Event Decoration Assets - Manage reusable decoration items - Maintain a simple inventory log to track usage, condition, and storage location—supporting better planning and cost control. • Support Event Preparation for Aesculap Academy Activities - Logistics and material organization. - Course registration, certificate preparation, flyer editing. • Help with Internal Communication and Documentation for Marketing-Related Events and Training - Product training preparation, recording, filming, check-in and check-out. • Support Simple Data Entry and File Management - Help update internal tracking sheets (e.g., participant lists, inventory for special price items). - Organize shared folders and ensure files are properly named and stored. - Support copy-paste tasks such as updating license numbers after license review. - Preview survey results (some events use handwritten notes and participant info that need to be keyed in). 【柏朗實習生 #4】來認識 Outpatient Market Intern, Eunice! https://youtu.be/KEyvDUxJ1Ds 【柏朗實習生 #2】來認識 Sales & Marketing Intern, Shelly! https://youtu.be/Cjhkik9Stis

1. 基因檢測產品開發。 2. 期刊文獻收集閱讀。 3. 分析次世代定序實驗數據。 4. 執行次世代定序實驗與導入新興技術與應用。 5. 主管交辦事項。 【加分(薪)項目】 1. 具認證實驗室工作經驗，如 CAP、TAF/ISO15189醫學實驗室、或TFDA/LDTS實驗室。 2. 具次世代定序操作(Illumina、MGI、Ion Torrent)與應用經驗(WES、RNAseq等)。 3. 熟悉相關周邊儀器原理及使用(qPCR/BioAnalyzer/Fragment Analyzer/Qubit等。 4. 依據學歷及經歷調整薪資及助理研究員、副研究員或研究員職缺。

【Responsibilities and Primary Activities】 Project ：市場准入公開資訊彙整站／儀表板（Dashboard／Portal） 詳細工作任務：   • 收集公司相關治療領域之藥品於台灣及國際主要市場的上市許可證現況與健保給付狀態，包括申請進度、核准進度、核准條件、市場價格變動等相關資訊   • 更新彙整國內外相關市場准入政策、相關主管機關公告資訊(如專案議題之相關法源規範、醫療預算專款規劃利用、特定治療領域政策重點)   • 搜集並整合指定治療領域之相關藥品公開臨床試驗結果、醫學期刊發表、公開會議記錄或審查結論   • 配合團隊需求，將所有上述公開資訊分類、整理，優化資訊視覺化、查找邏輯及篩選條件，發展一站式可批次更新、查詢與比對功能 (如excel 或dashboard)   • 製作/修訂查詢指引與平台操作手冊，協助同仁有效利用資料 Andy Kuo 郭先生 Direct : 02-7718-8834 Mail : Andy.kuo@adecco.com Line: @527ccida

☆ 短期合約半年，時薪200-250依經驗核薪☆ 【Requirements】 • Set up suppliers (including patient orgs, HCPs) • Draft Work Orders, Change Orders, Master Service Agreements, Single Service Agreements, Sponsorship grants for Patient Advocacy Groups • Coordinate Speaker Agreement forms • Facilitate contract signing • Ensure contracting periods are up to date 【我們希望你...】 • 具備外商行政經驗尤佳 • 英文能力精通（聽說讀寫／內部文件以英文為主） • 個性活潑、善於團隊合作 • 機靈、反應快

DISCO與臺科大化工系蔡伸隆教授、國際處合作，已獲得教育部114年「學海築夢」計畫補助。 【實習期間】 2026/01/05(一)-01/09(五) DISCO台北辦公室 (時薪200元) 2026/01/10(六)-02/11(三) DISCO JAPAN 東京總公司 (僅提供住宿) 【實習內容】 ・半導體相關技術課程、DISCO技術(切‧削‧磨) 原理 ・機台構造講解、實機訓練 ・與DISCO應用工程師㇐同進行實驗研究(數據分析) ・企業組織經營活動 【條件需求】 ・就讀台灣理工相關科系大三以上在學生 ・日文可流暢溝通(口頭、書信)程度 ・實習期間須全程參與 【實習地點】 ・台北辦公室: 台灣 新北市新店區寶橋路 ・東京總公司: 日本 東京都大田區大森北