「恭賀 Fortrea 官方Line 2.0 全新上線！」的相似工作

This is a sourcing req. for the upcoming new hire needs. Summary of Responsibilities • Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable) • Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines • Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. • Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and aggregate reports. • Perform peer/independent QC of Safety reports as needed. • Work with Data Management or client on reconciliation of safety databases, if appropriate. • Maintain a strong understanding of Fortrea's safety database conventions or client-specific database conventions, as appropriate. • Maintains a comprehensive understanding of Fortrea PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance. • Assist in signal detection, trend, and pattern recognition activities, as appropriate ¨ Monitor workflow for assigned studies/programs to ensure all the timelines are met. • Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate. • Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data provided. • Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed. • Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safetyspecific plans under supervision. • Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project. • Actively participates in project team and client meetings and liaise with clients, where appropriate. • Assist with proactive quality issue resolution and implementation of actions, as needed. • Support audit or inspection preparations • Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients. • Assist with the set-up of, and the provision of data to Safety Committees/DSMBs ¨ Build and maintain good PSS relationships across functional units. • Demonstrate role-specific Competencies and company values on a consistent basis. • Assist in the co-ordination of endpoint committees, as required. • Any other duties as assigned by management. Qualifications(Minimum Required): • BS/BA + 2 years of safety experience or 3-4 years of relevant experience • MS/MA + 2 years of safety experience or 2-3 years of relevant experience Experience(Minimum Required): •Good knowledge and understanding of Taiwan Pharmacovigilance regulations and guidelines. •Extensive experience in communication, liaison and consultation with Taiwan regulatory authorities. •Proficient in the regulatory submission process for drug safety reports to Taiwan FDA.

1. 臨床試驗的規劃與執行，包括臨床試驗流程監控、Phase 1 臨床數據分析、Phase 1/2 & Phase 2 試驗設計所需之背景資料收集與解讀。 2. 規劃並推進 長效針劑產品 BE study，包含CRO選擇、資源配置與時程管控，確保與整體 研發計畫一致。 3. 進行臨床數據與 藥理/藥代（PK/PD）分析 之審查與解讀，並撰寫醫學與科學報告，以支 持法規申請與內部決策。 4. 協助安全性監測（SAE/AE 評估、signal detection）與真實世界/背景數據分析，確保受 試者保護與醫學合規性。

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。

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.

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。

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

職缺描述： 我們正在尋找一位具備創意思維、熟悉藥品／醫材／日用品廣告規範，並擁有敬業精神的行銷經理。此職位需要您能夠運用創新策略推廣醫藥／藥材／日用品，同時嚴格遵守相關法規，確保行銷活動的合規性與有效性。此外，您需精通簡報製作工具，如 PowerPoint 和 Canva，以有效傳達行銷方案。 工作內容： 1. 行銷策略： 進行市場、消費者與競爭者分析，制定符合醫藥行業規範的行銷策略。 2. 擬定行銷目標： 定位品牌 STP（市場細分、目標市場、品牌定位），提升品牌知名度與產品銷量。 3. 執行行銷組合： 策劃並執行數位行銷、社群經營、行銷傳播宣傳活動，制定廣告與創意企劃案，評估廣告效益，分析商品販售成效，並協助相關人員進行教育訓練。 4. 預測可行性： 進行行銷績效評估，調整未來規劃，設定預計目標 KPI，並控制行銷預算。 5. 主管交辦事項： 完成主管指派的其他任務。 職位要求： 創意思維： 能夠發想創新概念，並運用於行銷活動中，提升品牌影響力。 熟悉藥品及醫療器材廣告規範： 了解並遵守相關法規，如《藥事法》及其施行細則，確保行銷活動的合規性。 敬業精神： 對工作充滿熱情，注重細節，追求卓越，並以高標準完成任務。 簡報製作能力： 精通 PowerPoint 和 Canva 等簡報工具，能夠製作具視覺吸引力且專業的簡報。 基本平面設計技能： 如：Adobe Photoshop、Illustrator 等平面設計軟體，能夠製作或指導具視覺吸引力的設計。 熟悉 AI 工具： 如 ChatGPT、AI 繪圖等，能夠應用於行銷專案的規劃、提案、執行及文案撰寫，包括行銷活動、影片腳本及創意發想。 創新行銷手法： 具備操作其他創新行銷手法及口碑行銷的能力（KOL、論壇、Facebook 社團、LINE 社群）。 社群經營能力： 能夠進行網站、Facebook、Instagram 等平台的文案內容企劃、操作與管理。 短影音製作： 熟悉短影音製作，具備 Adobe Photoshop、Illustrator 等平面設計能力。 AI 影音製作： 若懂得 AI 相關影音製作尤佳。 面試時請攜帶作品集，並準備可現場使用的 AI 工具。 若您確實閱讀了完整的職缺說明，請在自我推薦信內加入『我符合此職位所需的能力與經驗，對此工作充滿興趣』。

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.

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 and project management? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.

*此為Adecco外包職缺，合約期間為半年，後續將依表現與營運視況延長* *歡迎將履歷郵寄至[email protected] 【Job description】 This role also needs to manage data platform including customer, performance and digital channels to support data consolidation, alignment and analytics. - Data and platform management and enhancement - Understand deeply of company’s data bases with the capabilities to manage data base with accuracy and efficiency. - Pilot, accelerate and maintain digital channels and platforms to support company data and digital strategy. - Contact window of region or global for platform governance and enhancement. - Data consolidation - Organize, manage, and deliver data consolidation form different sources and platform to provide comprehensive review in support business analytic team. - To generate data in supporting digital engagement performance tracking. - Introduce contemporary data security, data privacy. 【Ideal Background】 1. 1 year experience in analytics or data science in the FMCG/Tech/Healthcare / Biotech/ OTC companies with strong knowledge of statistics, visualization, data preprocessing, and data analytics. Pharma Company is a plus. 2. Proficiency with data mining, mathematics, and statistical analysis 3. Experience with Excel, PowerPoint, SQL, and Power BI. 4. Strong communication and good team player, and able build alignments 5. Strong technical skills, data-driven and result-oriented thinking 6. Fluent in English and Mandarin

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。

主要職務: 1. New project evaluation, perform literature study 2. Pharmacology and PK/PD data interpretation 3. Assist nonclinical & clinical CRO management 4. Project management for new drug development 詳細職務內容: 1. In-depth study on marketed drugs and their target indications, consider MOA, PK/PD profile, formulation design, brainstorming for new project ideas. 2. Various literature search and information gathering per supervisor’s request 3. Assist in nonclinical study design. 4. Assist in CRO contracting and follow up study execution. 5. Data processing & provide scientific interpretation. 6. Serve as PM role in various projects, taking meeting minutes, tracking development progress

臨床試驗案件執行管理等相關工作 1.規劃及執行臨床試驗專案計畫. 2.協調參與試驗團隊，管控計畫進度並確保符合GCP試驗標準程序. 3.監督試驗過程與進度，並追蹤審查試驗成效. 4.專案障礙排除與危機管理. 5.合同項目執行規劃與驗收. 6.客戶關係維護. 7.監督試驗文件品質. 8.支援公司業務推廣工作.

負責原料藥藥品查驗登記及DMF審查、展延及變更 協助食品添加物查驗登記、展延、變更 聯繫國外製造廠索取查驗登記文件 辦理自用原料、試製、賦形劑、食品免驗等專案進口申請 瞭解藥事法規及查驗登記相關規定，並將資料建檔管理，隨時更新確保公司遵循政府法令規定 瞭解國內食品添加物進口和販售之相關規定 熟悉藥品查登規定及流程，能匯整公司產品查驗登記資料達到TFDA的要求

1. 執行動物實驗、細胞試驗與分生試驗 2. 執行藥物篩選與臨床前試驗(藥理、毒理) 3. 試驗方法整理與數據分析整理 4. 藥物開發相關參考文獻搜尋與整理

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. 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.

具有以下經驗: 實質2年以上試驗案監測經驗 對於計畫書有深度的理解能力 蒐集資料並且適當解決 良好的溝通特質 精準的時間管理

【Job Description / Capsule】 WHAT YOU WILL DO: - Collaborate closely with Marketing team in Oncology Business Unit to develop and execute campaign strategies and marketing collateral. - Support to manage the end-to-end campaign lifecycle, including content creation, approval workflows, execution monitoring, performance tracking, and data-driven analysis. - Serve as a liaison for internal teams and external vendors, ensuring clear and timely communication. - Provide logistical support for Marketing events, coordinating all associated operational details. - Oversee alliance coordination activities and maintain accurate data records. - Organize and facilitate internal meetings to support Marketing initiatives. Anne Yao Direct：02-7720-5802 Email：[email protected]