「醫藥學術副理/專員 Medical Associate / Medical Writer」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

1. 規劃各新藥開發案產品發展策略：進一步了解全球生技產業之研發趨勢、機會與相關資訊蒐集，並且擬定各目標市場之臨床開發策略與執行計畫。 2. 開發與建立目標市場重要合作專家夥伴關係，確保各臨床試驗案於目標市場之品質、速度與成功，並協助全球品牌價值維護：維護外部夥伴與重要領域專家關係。 3. 發現新的臨床研究機會：與外部關係建立與互動，從中發現新的研究與機會點。 4. 教育訓練：內部員工和外部客戶(醫師、護理師或個管師等)

【工作內容】　 1. 有品牌廣告代理操作經驗，能提案和執行 2. 行銷活動規劃、執行、檢討優化及預算控管 ( 熟悉各社群平台及媒體特性找尋適合的KOL ) 3. 能釐清品牌客戶需求，針對需求提出解決方案與執行 4. 管理、規劃、溝通KOL合作產出的品質及時程，並追蹤及分析個別配合成效 5. 彙整數據報表、追蹤相關成效 【必要條件】 1. 一年以上品牌端、媒體或廣告代理商經驗。 2. KOL行銷經驗( 提案－執行－結案，請提出相關規劃書或是案例 ) 3. 良好溝通和協商技巧，擅長對外對內溝通及反饋 4. 重視團隊合作，並與客戶保持良好的互動 5. 熟悉數位媒體以及社群網路行銷市場環境 6. 具備團隊精神，協助團隊共同達成工作目標 【加分條件】 1.對於醫療領域有熱情與好奇心，對於醫療人員生態有興趣 2.細心負責、主動性高、溝通能力佳，懂得應變解決問題。 3.執行力、抗壓性強，思考邏輯清晰、可獨立完成交辦事項，並具備良好情緒管理能力。 4.良好的溝通與公關能力，以正面的態度思考問題並獨立解決，保持樂觀 5.需具時事話題敏銳度及掌握網路行銷趨勢，重度關注網路時事，長期觀察FB/IG/Youtuber/TikToker/Podcaster等KOL生態且有基本認識。 ～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～ 【公司簡介 | 醫淬思Mediterest】 https://www.instagram.com/mediterest.inc/ 醫淬思是台灣最大的醫療社群聯盟，已有超過350位醫療會員 包含醫師、牙醫師、藥師、護理師、治療師、營養師…等等 社群總粉絲數超過500萬；文章總曝光次數超過6000萬次。 醫淬思許多知名企業皆為合作夥伴，如：統一集團、台新銀行、全球最大醫學論文出版商Elsevier等；除跨界合作外，醫淬思亦專注於如何擴展醫療專業在社群的影響力，疫情期間主辦 #用故事突破同溫層 社群串連活動，拉近醫護人員與大眾的距離，獲大紀元、聯合報近50篇報導。 醫淬思在各項新創競賽獲獎，包含科技新創、服務新創、CSR新創 種子輪獲台灣大學投資入股，估值超過千萬。 升遷管道順暢，主管職級享有優先認股權利。 合夥千坪健檢中心，員工福利包含價值超過三萬元的旗艦健檢！ 品牌好禮員工優先體驗！Garmin手錶、Kielh's保養品、大研生醫保健品！ https://www.instagram.com/p/CoCYdn9pmEf/

學歷要求：具公衛、流病、藥學相關領域碩士(含)以上學位者；具藥師執照者尤佳。 工作內容： 1.藥品、特材以及醫療服務的醫療科技評估業務。 2.醫療照護或社會福利方面特定主題的研究計畫。 3.業務相關行政工作。 4.其他交辦事項。 請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

〔工作內容〕 Major tasks and responsibilities • Meeting coordination (including multi-countries meeting/ PH annual meeting/ Advisory Boards) including overseeing logistics of technical support for various meeting formats. • Process monthly reports of Content Factory, Baylearn, CAC. Technically support newsletter publication and data collection. • Support medical governance tasks. • Administrative support (travel arrangements, office supply purchasing and reimbursement) for Medical Director. • Support IIR/NIS submission and site activities, follow up status, advance payment application. • Set up Newcomer for relevant systems and providing orientation of these systems, as well as the process of termination to employee. • Ad-hoc projects as assigned by Country Medical Director to support operations of the medical department, such as drafting study document archiving service agreement. • Timely milestone/ status update in Mont Blanc and Global team to ensure governance and smooth running of PSP • Administrative coordination of PSP in consultation with program responsible including Medical Leads and Product Managers to ensure medical governance and compliance of these programs Value added to the success of the company • Ensure governance and smooth running of patient support programs in particular patient support disease management programs. • Medical department super user of various systems such as SmartBuy, SAP, etc. • Coordination and implementation of medical department processes. • Support administrative tasks of Medical Director. • Support the MGME manager in maintaining proper documentation and coordinating training, thereby ensuring audit readiness and optimizing medical capabilities. 〔需求條件〕 Education: Bachelors degree and above, medicine/pharmacy/biological sciences preferred. Experience: At least 2 years experience in medical department of Pharma industry. Competencies: a) General: Good command of English, advanced computer skills in MS office, Integrity b) Judgements/decisions: Excellent problem-solving skills, able to work independently c) Contacts and Communications: Good communication and presentation skills d) Other: Strong project management and multi-tasking capability 〔任用方式〕 此為派遣職缺 〔工作地點〕 台北市信義區 台北101 〔工作時間〕 週一至週五 週休二日 國定假日休假 〔薪資福利〕 依照學經歷背景核定

1.Review, develop, and maintain regulatory documents and safety databases 2.Conduct PV: receiving, processing, submitting, maintaining safety cases/regulatory data, and medical coding 3.Establish and facilitate communication with study sites, the EC/IRB, and health authorities 4.As appropriate, assist Bestat and relevant parties in facilitating medical monitoring and regulatory processes, management, and policies

工作內容： 1.參與及協助臨床試驗相關計劃的送審、執行、監督及回報。 2.臨床試驗相關個案報告整理及追蹤。 3.協助臨床試驗監測及病人收案。 4.定期出差至醫院執行試驗監測、確保試驗收案符合預期、臨床試驗執行符合GCP、計劃書與相關法規規定。 5.醫院IRB各項行政與業務處理和維護、相關事務溝通協調 6.提供PI/Site選擇之評估建議與回饋。。 7.其他主管交辦事項。 工作型態： 需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給臨床研究經理(CRM)，出差天數依據試驗案的進程而定。

協助醫學專業人士或藥廠優化研究設計，並以英文撰寫與修改學術文件及研究計畫，確保內容的專業性與準確性。 與醫療機構及研究單位建立長期穩健的合作關係，依照客戶情況提供專業建議，解讀臨床數據，搜尋學術文獻找出臨床研究的價值，協助解決研究過程中的挑戰，以提升研究品質與學術產出價值。

The Medical Science Liaison (MSL) acts as a critical bridge between the company and the medical community. This role focuses on building and maintaining strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and relevant medical organizations. The MSL will ensure the accurate dissemination of medical and scientific information, supporting the clinical adoption and academic collaboration of the company’s medical products and contracts. Key Responsibilities: • Serve as a scientific liaison to the medical/ scientific community • Ensure the appropriate dissemination of scientific and clinical information regarding marketed and pipeline compounds, in a timely, ethical and customer-focused manner • Implement clinical and educational strategies to support Company-sponsored trials, to facilitate investigator-initiated studies, and to develop educational initiatives • Work to pair key customer's educational and research needs with available Company resources and provide the latest emerging data in response to specific healthcare professional inquiries • Respond to unsolicited requests for scientific, technical or clinical information about Company products • Engage in discussions with thought leaders at key academic centers and professional organizations in its geographical perimeter. Topic areas include: contrast agents, medical devices, medical imaging, interventional radiology, cardiovascular, neurology and oncology • Facilitate preclinical or clinical research or publication interests by thought leaders • Represent Company at professional meetings, congresses, local symposia and partner-sponsored meetings. Interpret and report findings with recommendations for action to relevant Company personnel • Provide educational support (e.g., continuing education programs) as requested by Sales staff • Provide onsite support and assistance during product evaluation or trial process • Report changes in medical practices • Provide support in collating and reporting data in connection with safety events that arise in the context of use of Company products • Provide assistance and clinical insight on special projects in conjunction with Marketing, Sales, Clinical Development, or Compliance as directed

1.產業導向的嗅覺科學(Olfactory Science) 相關產品研發及企劃工作。 2.嗅覺科學(Olfactory Science)與 Endocrine System, Immune System及Central Nervous System 等相關研究。 。 3. 產品相關資訊調查及收集。 4. 期刊論文撰寫。

1. 各階段臨床試驗之計畫書設計評估、試驗數據及報告之解析評估。 2. 醫藥學術及臨床相關技術性資料之蒐尋與彙整評估。 3. 熟悉藥品查登規定及流程，能匯整公司產品查驗登記資料確認符合國內外(例如:歐美地區)衛生單位要求。 4. 充分了解藥事法規及查驗登記相關規定，隨時更新確保遵循政府法令規定。 5. 內部及外部之試驗協同與委託等單位之溝通整合，以及臨床試驗監測與訪視。 6. 國內外藥物資料文獻閱讀及彙整。 7. 其他主管交辦事項。

1. 獨立作業而且能掌握研發專案的時程及成果交付。 2. 具管理內部資源之能力，控制部門/或專案活動之預算。 3. 臨床試驗文件撰寫和/或審閱。 4. 評估專案相關議題並研擬解決方案，與專案主管、團隊及外部合作者、委外供應者進行協調溝通。 5. 委外研究、CRO之評估、執行追蹤及品質管理。 6. 各國IND申請及臨床驗證之規劃及執行。 7. 具供應商管理經驗。 8. 具有CRA經驗尤佳。

歡迎透過104投遞履歷，或將履歷mail至：[email protected]（信件標題請複製職務名稱） 《需求條件》 1、大學以上學歷畢業，具有1至2年製藥行業行政經驗者佳。 2、能夠同時處理多項任務，流利書寫英語。 3、具備良好人際關係與溝通能力。 4、熟練使用Microsoft O365、辦公管理軟件。 《合作方式》 長期派遣 《工作地點》 臺北市信義區信義路5段 《工作內容》 Major tasks and responsibilities • Meeting coordination (including multi-countries meeting/ PH annual meeting/ Advisory Boards) including overseeing logistics of technical support for various meeting formats. • Process monthly reports of Content Factory, Baylearn, CAC. Technically support newsletter publication and data collection. • Support medical governance tasks. • Administrative support (travel arrangements, office supply purchasing and reimbursement) for Medical Director. • Support IIR/NIS submission and site activities, follow up status, advance payment application. • Set up Newcomer for relevant systems and providing orientation of these systems, as well as the process of termination to employee. • Ad-hoc projects as assigned by Country Medical Director to support operations of the medical department, such as drafting study document archiving service agreement. • Timely milestone/ status update in Mont Blanc and Global team to ensure governance and smooth running of PSP • Administrative coordination of PSP in consultation with program responsible including Medical Leads and Product Managers to ensure medical governance and compliance of these programs Value added to the success of the company • Ensure governance and smooth running of patient support programs in particular patient support disease management programs. • Medical department super user of various systems such as SmartBuy, SAP, etc. • Coordination and implementation of medical department processes. • Support administrative tasks of Medical Director. • Support the MGME manager in maintaining proper documentation and coordinating training, thereby ensuring audit readiness and optimizing medical capabilities. 《工作時間》 1、週一至週五 0900-1800 2、週休二日 《薪資與福利》 1、月薪6萬(依學經歷核定) 2、年終獎金

1. 協助醫療器材臨床試驗設計規劃 2. 協助撰寫及編輯臨床試驗文件，包括但不限於臨床計畫書、研究者⼿冊、臨床研究報告及知情同意書。 3. 協助學術文獻彙整與評估 4. 協助臨床評估報告撰寫 5. 各國衛⽣主管機構及IRB機構之申請文件、監管文件 (包含安全性報告通報) 之撰寫及回覆。

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。

 Work with GSK third party (MOC, Marketing Operation Center) to complete product requested jobs (including Veeva email, Mass email, video, eDetails, Web pages, Print, Webinar Content) in content lab. (60%)  Work with Commercial and MOC team to complete required marketing ankle and reference in content lab. (20%) Assist in communicating and tracking jobs delivery on time (ex: Be able to communicate with contact parts based on planned schedule and actions) (20%)

工作內容: 1. Identify KEEs, and segment KEEs with development & engagement plan 2. Establish rapport with scientific interactions: disseminate data, respond to unsolicited medical information requests, liaise investigator-initiated studies and external cooperative studies 3. Collect insight and external intelligence in a timely, support strategic planning for medical affairs and the brand 4. Execute MA plans (professional and patient group) following MA strategy 5. Localize global medical materials (incl. medical deck, standard response, QA, etc.) 6. Support Trial, MA studies, and medical programs (phase Ⅰ-Ⅲ, Ⅳ, IIS, EAP) 7. Conduct other assignments from leadership team

1.國外醫療器材產品認證註冊申請作業(FDA 510K申請)。 2.國內外醫療器材法規認證事務及相關法規、標準之收集與更新。 3.國內外醫療器材查驗登記申請相關事務。 4.ISO品質系統維護及管理。

1.學術支持： 提供公司產品的學術支持，協助醫學專業人士更深入地了解產品的應用、效果和安全性。這可能包括提供文獻資料、培訓、以及回答醫學專業人士的相關問題。 2.醫學教育： 負責開發和提供醫學教育材料，以向醫學專業人士、病患和其他相關方提供相關資訊。這可以包括研討會、培訓課程、線上資源等。 3.學術合作： 與學術機構、醫學中心和其他相關實體建立合作關係。這可能包括共同研究、臨床試驗、學術會議等，以推動科學研究和知識的進展。 4.科學溝通： 負責將科學知識轉化成易於理解的形式，以便向不同的受眾（如醫學專業人士、病患、媒體）傳達。這可能包括撰寫學術文章、發表演講、製作宣傳材料等。 5.產品策略支持: 與其他部門合作，將學術和科學知識納入公司的產品策略中。這可以幫助公司更好地理解市場需求，並確保產品的發展和推廣符合科學標準和法規。 6.文書作業處理，會編制在行銷部，須執行相關之工作。 7.有醫材相關經驗尤佳

協助醫學專業人士或藥廠優化研究設計，並以英文撰寫與修改學術文件及研究計畫，確保內容的專業性與準確性。 與醫療機構及研究單位建立長期穩健的合作關係，依照客戶情況提供專業建議，解讀臨床數據，搜尋學術文獻找出臨床研究的價值，協助解決研究過程中的挑戰，以提升研究品質與學術產出價值。