Project Planning and Coordinator

這個工作參與多個上中下游的動物疫苗研發專案及研發實驗室專案，專案類型包含魚病毒疫苗計劃(口服/注射)、魚菌疫苗計劃、豬病毒疫苗(製程放大)及技術授權等，年度研究計畫預算規模約數百萬至千萬不等；在專案中，對外需要與學校老師或研究單位洽談計畫合作方案，對內需要與法國總部的研發/工廠/QC/QA合作討論，或將研發成果技轉到維克總部或關係企業(例如歐洲或中南美洲國家)，或準備國內外產品登記之技術文件以販售疫苗產品至東南亞及中南美洲等國家。 過程中，將接觸一條龍的研發流程以及國際合作機會。您需要到屏東研發實驗室，實地瞭解製程放大的研發過程；與疫苗工廠同仁合作，學習GMP規範；也有機會與法國研發專家或臨床部門專家學習實驗設計；每天接觸公司最新的技術、產品知識及相關法規。 你的英文溝通能力、專業知識及計畫執行能力，影響公司的產品研發決策及研發預算多寡；你的工作品質及團隊合作能力，影響研發的能量及效率；你的工作成果，決定新產品上市速度。歡迎加入我們，在這裏，你看到的眼界將不一樣。 Coordinate and execute the RD project (1)To monitor or organize the studies into realistic time sequences (2)To carry out the plan by initiating studies in minimizing the cost, timing (eg. by preparing the transfer of biomaterial, vaccine sample and etc. in advance) Organization of studies To execute the development operational plan by: (1)Prepare concept papers and timeline by tasks, based on objectives defined by the company, taking into account guidelines and local regulation (2)Collect or write protocol based on the defined concept paper and have the protocol reviewed, then follow the execution by interacting with actors to optimize time and resources (3)Communicate with the legal between parties in order to finalize the contract and reach the agreement. (4)Follow up on resources (contract, sample delivery, timing, expenses..) and apply for the payment for studies. (5)Organize meetings or R&D activities whenever necessary (6)Writing meeting minutes, action plans, and the follow-up after the meetings. Participate in product registration (1)Prepare a technical dossier (Part II) to get registration in Taiwan and/or overseas. (2)Review question of authorities, transmit to professors or answer directly, taking into account defined strategy and timing constraints (3)In case of variation, for in-line extensions (addition of new packaging, an extension of shelf life, the addition of indication or target species and etc) to prepare the dossier and answer the questions. Support to organization of key project meetings (1)Organize meetings (2)Collect progress from team members, prepare slides for the meetings (3)Maintain and update the Project Team Members: Speakers & Members on the list (4)Archive files on cloud drives and circulate to the team members. (5)Writing meeting minutes, action plans, and the follow-up. 5.Support the admin work related to RD activities (1)Payment application (2)Monthly maintain and follow up with RD team for the cashflow of expense of external studies, shipment and translation (3)Monthly management of paythrough table for external studies with Finance team (4)Budget proposal for next year related to RD studies, such as shipment, translation, etc. (5)RD document translation and proofreading (6)Contract management (7)Supporting to maintain friendly relations with institutions for RD projects (8)Supporting the communication with ATP when the RD lab in Pingtung has some issues.