公司介紹

產業類別

聯絡人

賴小姐

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

資本額

傳真

暫不提供

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)

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

工作性質
廠商排序
10/16
台北市南港區4年以上碩士待遇面議
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
應徵
10/16
台北市南港區1年以上碩士待遇面議
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.
應徵
10/16
台北市南港區3年以上碩士待遇面議
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。
應徵
10/16
台北市南港區1年以上碩士待遇面議
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.
應徵
10/16
台北市南港區5年以上碩士以上待遇面議
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.
應徵
10/16
台北市南港區經歷不拘大學待遇面議
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.
應徵
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