找頭鹿 智能客服
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公司介紹
產業描述
醫療保健服務業：法規申請服務、臨床試驗規劃管理、專案研究及管理
電話
02-27891060
員工人數
25人
地址
台北市南港區三重路66號11樓之3
公司簡介
Efficient Pharma Management Corp. (EffPha) accelerate the development of drug candidates by defining the right strategy, avoiding or minimizing delays in pre-clinical development and assuring timely and accurate study outcomes. EffPha effectively manages every step to ensure our clients have a rapid, cost effective, and quality development program. Efficient Pharma Management Corp. (EffPha) provides drug development services for pharmaceutical companies. Our services focus on information integration for the submission package preparation, strategic planning, and efficient management of the clinical study to accelerate your drug development to approval. With extensive regulatory experience and multi-cultural familiarity, EffPha serves as your regional hub in Asia, and bridges the gaps between Asian and global pharmaceutical industries to widen your market reach.
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主要商品 / 服務項目
●Clinical Services ◎Medical Writing ◎Clinical Study Planning ◎Clinical Study Management and Monitoring (Phase I-VI) ◎Data Management/Biostatistics ●Regulatory Services ◎Regulatory Gap Analysis ◎Technical Writing/ Compilation (ICH/CTD) ◎US FDA, TFDA/CDE Consultation Meeting Preparation ◎eCTD Publishing and Filing to US FDA ◎IND Submission/Maintenance ◎NDA Submission (NDA, BLA, ANDA) ◎Product Registration ●Pre-Clinical Development Management ●Product Development Evaluation ●Technical and Regulatory Consultation
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公司環境照片(6張)
溫暖的團隊文化。 寬敞、舒適、充滿藝術感的全新辦公室。
映入眼簾的是明亮的自然光，透過寬敞的窗戶灑落在清新的綠植和舒適的家具上，讓人感到舒適愜意。
寬敞而明亮的會議室空間，配備了先進的投影設備和視訊會議系統，保證遠程參與者和來賓的溝通品質。
牆上懸掛著各種藝術作品，提供靈感和創意。
不僅是一個工作場所，更是一個充滿活力和創意的社區，讓員工可以在這裡找到工作與生活的平衡，激發出最佳潛能。同時，綠色植物和自然元素使整個空間更加舒適有生氣。
辦公室的設計注重開放性和互動性，包括寬敞的共享區域和舒適的休閒角落。這裡有許多不同形式的座位選擇，從高腳凳到舒適的沙發，讓員工可以根據自己的需要和喜好選擇放鬆方式。
福利制度
●周休二日、彈性上下班 ●勞保、健保 ●員工團體保險 ●員工健康檢查 ●年度調薪、績效獎金、年終獎金、端午/中秋禮券 ●不定期聚餐或慶生會 ●年終尾牙或春酒 ●員工旅遊活動 ●員工休憩區、設置研磨咖啡機免費使用
工作機會
10/16
1. 臨床試驗法規審查資料準備與送件
2. 與試驗團隊聯絡及問題之溝通協調
3. 臨床試驗執行與收案進度追蹤
4. 臨床試驗監測與試驗品質控管
5. 臨床試驗相關資料整理歸檔
6. 其它交辦事項
10/16
1. Assist in performing project proposal tasks including drafting budget quotations.
2. Perform administrative management processes, including business document/ file archiving and management, payment processing, and project closure.
3.Meeting coordination and arrangements, assist in project database integration and update project-related master lists.
4. Assist in participating in biotech/medical-related exhibitions and marketing activities, collect and compile client information and conduct periodic client visits.
5. Provide business projects support and perform other tasks assigned by Supervisors.
6. SOP revised and updated by BD director's instruction.
10/16
1. 拜訪既有客戶執行業務接洽與管理，提升客戶忠誠度。
2. 依據公司策略，開拓新客戶及市場以達成業績目標。
3. 負責國際客戶及合作夥伴之溝通與協調。
4. 業務承接規劃與可行性評估以及內部資源協調。
5. 專案執行進度之追蹤與協調。
6. 規劃公司業務推動及廣宣活動。
7. 適度參與專案業務之研究與執行。
8. 其他主管交辦之工作。
10/16
1. Develop and review the case report form (CRF).
2. Develop and review the database specification.
3. Develop and review the database structure on the database builder.
4. Develop and review the data validation specification.
5. Conduct the database validations including the user acceptance testing.
6. Develop and maintain the CRF library.
7. Develop and maintain the edit checks (ECS) library.
8. Develop and conduct the data review process and dummy data generation.
9. Oversee and coordinate clinical data integration activities as a DMPM.
10. Develop and update the templates of related processes.
11. Develop and manage the working process and standard operating procedures (SOPs).
12. Act as a mentor for the Associate Clinical Data Scientist I
13. Complete other tasks or assignments requested by the Supervisor.
10/16
1. Work with cross-functional team to lead and manage projects.
2. Keep current with the latest regulations and guidelines. Interpret relevant regulatory guidelines. Communicate with regulatory agencies.
3. Gather, analyze and organize scientific/technical information.
4. Review, draft and edit technical documents and reports. Ensure that all content complies with regulatory standards and guidelines.
5. Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
6. Train and provide support to other staff.
7. Scientific literature search, review and information integration.
10/16
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.
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