職位描述
職位描述: CMC項(xiàng)目管理主管/經(jīng)理CMC中國，方達(dá)醫(yī)藥技術(shù)有限公司，方達(dá)醫(yī)藥技術(shù)有限公司現(xiàn)為公司的CMC （配方，工藝，分析，質(zhì)量保證和生產(chǎn)）外包服務(wù)項(xiàng)目尋求一名項(xiàng)目管理經(jīng)理。受聘者將直接向方達(dá)CMC中國的總經(jīng)理匯報(bào)，負(fù)責(zé)協(xié)調(diào)所有CMC產(chǎn)品開發(fā)和生命周期管理的外包服務(wù)活動(dòng)。該職位的辦公地點(diǎn)在中國蘇州，并根據(jù)工作需要，完成訪問國內(nèi)客戶的出差任務(wù)。 該職位還負(fù)責(zé)處理與方達(dá)外包服務(wù)相關(guān)的事宜，包括準(zhǔn)備投標(biāo)回復(fù)，報(bào)價(jià)單，宣傳材料等。
崗位職責(zé)：1. 建立CMC服務(wù)策略和協(xié)調(diào)CMC項(xiàng)目進(jìn)展2. 參與全球項(xiàng)目團(tuán)隊(duì)的項(xiàng)目管理，與醫(yī)療，運(yùn)營，法規(guī)等功能部門的合作3. 督促和幫助CMC團(tuán)隊(duì)按時(shí)完成項(xiàng)目及到達(dá)里程碑4. 協(xié)作和管理其他CRO、CMO公司及外部合作伙伴5. 按需要，準(zhǔn)備相關(guān)的規(guī)范性文件（模塊3 ）和專利申請(qǐng)6. 編制項(xiàng)目預(yù)算，成本和資源7. 準(zhǔn)備投標(biāo)回復(fù)，定價(jià)總結(jié)，報(bào)價(jià)，協(xié)議等。8. 為銷售和項(xiàng)目管理準(zhǔn)備宣傳材料9. 根據(jù)指示參與開發(fā)和商業(yè)生產(chǎn)協(xié)議的談判10. 作為主要客戶關(guān)系經(jīng)理，專注于從現(xiàn)有的帳戶創(chuàng)造更多的業(yè)務(wù)11. 保持與研發(fā)人員，業(yè)務(wù)和高級(jí)管理人員的良好工作關(guān)系及有效溝通渠道，以確保所有帳戶/項(xiàng)目的有效管理和對(duì)客戶的需求的及時(shí)響應(yīng)。12. 完成管理團(tuán)隊(duì)指定的其他任務(wù)
任職要求：1. 至少3年在制藥行業(yè)管理CMC外包服務(wù)項(xiàng)目管理的工作經(jīng)驗(yàn)2. 本科以上學(xué)位，優(yōu)先考慮藥劑，分析化學(xué)或制藥工程專業(yè)3. 能夠有效地與客戶的科技、項(xiàng)目管理、采購、運(yùn)營、業(yè)務(wù)、及高級(jí)管理人員溝通4. 有據(jù)可查的項(xiàng)目管理經(jīng)歷，有外包服務(wù)項(xiàng)目管理經(jīng)驗(yàn)者優(yōu)先5. 能夠判斷項(xiàng)目的優(yōu)先等級(jí)和規(guī)劃切合實(shí)際的期限6. 具備對(duì)中國CFDA和美國FDA法規(guī)熟練扎實(shí)的知識(shí)及理解7. 流利的英語和普通話（口頭和書面）8. 精通的MS Excel，Word，PowerPoint，Outlook等軟件，掌握MS Project者優(yōu)先9. 具有進(jìn)取、開朗的性格、優(yōu)秀的溝通及人際交往能力、流暢和專業(yè)的演講水平10. 具有樂觀、開放的態(tài)度及面對(duì)挑戰(zhàn)的準(zhǔn)備11. 愿意且能夠根據(jù)需要出差，訪問客戶或者其他地點(diǎn)。
Responsibilities:1. Establishment of the CMC service strategy and coordination of CMC project activities2. Participate in global project teams, and collaborating with project management, Medical, Operations, Regulatory function etc.3. Driving and facilitating the CMC teams to meet project deadlines and reach milestones4. Collaboration with and management of CROs, CMOs and external partners5. Preparation of relevant regulatory documentation (module 3) and patent applications, when needed6. Preparation of project budgets on costs and resources7. Preparation of all required bid request responses, pricing summaries, quotations, agreements, etc.8. Prepare all promotional materials necessary to accomplish sales and project management duties9. Participate as instructed in the negotiation of development and commercial manufacturing agreements10. Act as the primary customer relationship manager with identified accounts focusing on generating more business from existing accounts, and /or from new accounts11. Develop and maintain good working relationships and effective communication with R&D staff, operations and senior management to ensure all account/project activities are effectively managed and responsive to the needs of the customer12. Other duties as assigned by management
Requirements::1. Minimum 3 years experience in managing CMC contract services projects in pharmaceutical industry2. BS/BA in a scientific discipline is required; ideally pharmacy, analytical chemistry or pharmaceutical engineering3. Ability to interact effectively with clients’ scientific, project management, procurement, operations, business and senior management staff4. Proven track record in project management; ideally contract services project management5. Ability to prioritize and plan realistic deadline6. Solid knowledge of the pharmaceutical industry in China and United States with a working understanding/proficiency of CFDA and FDA regulations7. Fluent (spoken & written) in both English and Mandarin8. Proficient in MS Excel, Word, PowerPoint, Outlook, and ideally MS Project9. Self-starting, outgoing individual with outstanding communication and interpersonal skills, as well as a polished and professional presentation style10. Optimistic, open minded and ready for challenges11. Willing and able to travel as required to meet with clients at their facilities or other locations
