職位描述
進(jìn)口藥品注冊(cè)新藥注冊(cè)
Role Purpose:
To provide support in regulatory project management operation, work closely with regulatory teams to track regulatory deliverables related to regulatory programs.
To provide support in regulatory project management operation, work closely with regulatory teams to track regulatory deliverables related to regulatory programs.
在注冊(cè)項(xiàng)目管理運(yùn)作方面提供支持，與注冊(cè)團(tuán)隊(duì)緊密合作，追蹤與注冊(cè)項(xiàng)目相關(guān)的注冊(cè)交付成果。
Key Accountabilities/Responsibilities:
1. Regulatory project coordination, tracking and monitoring for new products (IND/NDA) and established products (variation and renewal).
Key Accountabilities/Responsibilities:
1. Regulatory project coordination, tracking and monitoring for new products (IND/NDA) and established products (variation and renewal).
對(duì)新產(chǎn)品（研究性新藥申請(qǐng) / 新藥申請(qǐng)）和已上市產(chǎn)品（變更及續(xù)期）進(jìn)行法規(guī)項(xiàng)目的協(xié)調(diào)、跟蹤與監(jiān)測(cè)。
2. Regulatory data entry and information maintenance in certain systems.
2. Regulatory data entry and information maintenance in certain systems.
在特定系統(tǒng)中進(jìn)行法規(guī)數(shù)據(jù)錄入及信息維護(hù)。
3. Track functional project milestones (CMC, Clinical, Nonclinical, Submission and Operation) and other sub-team activities to ensure overall adherence to the project timeline regularly.
3. Track functional project milestones (CMC, Clinical, Nonclinical, Submission and Operation) and other sub-team activities to ensure overall adherence to the project timeline regularly.
定期跟蹤職能項(xiàng)目的關(guān)鍵節(jié)點(diǎn)（化學(xué)、制造和控制，臨床、非臨床、申報(bào)及運(yùn)營(yíng)）以及其他子團(tuán)隊(duì)的活動(dòng)，以確保整體嚴(yán)格遵守項(xiàng)目時(shí)間表。
4. Lead and coordinate project meetings to review project updates, including scheduling, preparing/distributing documentation and ensuring action items’ follow-up.
4. Lead and coordinate project meetings to review project updates, including scheduling, preparing/distributing documentation and ensuring action items’ follow-up.
主導(dǎo)并協(xié)調(diào)項(xiàng)目會(huì)議，對(duì)項(xiàng)目進(jìn)展進(jìn)行回顧，包括安排會(huì)議日程、準(zhǔn)備 / 分發(fā)文件資料以及確保跟進(jìn)各項(xiàng)待辦事項(xiàng)。
5. Provide support in Pharmaceutical/Vaccine Annual Report submission.
5. Provide support in Pharmaceutical/Vaccine Annual Report submission.
在藥品 / 疫苗年度報(bào)告提交方面提供支持。
6. Provide support in PSUR/DSUR document preparation.
6. Provide support in PSUR/DSUR document preparation.
在定期安全性更新報(bào)告 / 研發(fā)期間安全性更新報(bào)告文件編制方面提供支持。
7. Develop and maintain regulatory reports, trackers for communication, when needed.
7. Develop and maintain regulatory reports, trackers for communication, when needed.
在必要時(shí)制定并維護(hù)用于溝通的法規(guī)報(bào)告、跟蹤記錄表。
8. Management of project purchase order, fee payment, cost settlement and third-party communication according to company purchase policy.
8. Management of project purchase order, fee payment, cost settlement and third-party communication according to company purchase policy.
依據(jù)公司采購政策，管理項(xiàng)目采購訂單、費(fèi)用支付、成本結(jié)算以及與第三方的溝通事宜。
9. Develop and maintain PMO related process, where necessary.
9. Develop and maintain PMO related process, where necessary.
在必要時(shí)制定并維護(hù)與項(xiàng)目管理辦公室相關(guān)的流程。
10. Provide logistics and administrative support to HA meetings, department activities, when needed.
10. Provide logistics and administrative support to HA meetings, department activities, when needed.
在必要時(shí)為衛(wèi)生當(dāng)局會(huì)議、部門活動(dòng)提供后勤及行政支持。
11. Undertake any other duties assigned by line manager/team.
承擔(dān)直線經(jīng)理 / 團(tuán)隊(duì)交辦的其他任何任務(wù)。
11. Undertake any other duties assigned by line manager/team.
承擔(dān)直線經(jīng)理 / 團(tuán)隊(duì)交辦的其他任何任務(wù)。
Experience/Capabilities:
1. University degree in Medical/Pharmaceutical, Business management, English related major.
1. University degree in Medical/Pharmaceutical, Business management, English related major.
醫(yī)學(xué) / 藥學(xué)、企業(yè)管理、英語相關(guān)專業(yè)的大學(xué)學(xué)歷。
2. At least 1~3 year(s) relevant working experience in pharmaceutical company.
至少有 1 至 3 年在制藥公司的相關(guān)工作經(jīng)驗(yàn)。
2. At least 1~3 year(s) relevant working experience in pharmaceutical company.
至少有 1 至 3 年在制藥公司的相關(guān)工作經(jīng)驗(yàn)。
3. Good in English (oral and writte
具備良好的英語水平（口語及書面）。
4. Skilled in project management, data management and communication.
4. Skilled in project management, data management and communication.
熟練掌握項(xiàng)目管理、數(shù)據(jù)管理及溝通技巧。
5. Well organized and pay attention to details.
5. Well organized and pay attention to details.
條理清晰，注重細(xì)節(jié)。
6. Demonstrated ability to handle multiple assignments and projects accurately.
6. Demonstrated ability to handle multiple assignments and projects accurately.
經(jīng)證實(shí)具備準(zhǔn)確處理多項(xiàng)任務(wù)和項(xiàng)目的能力。
7. Demonstrate strong PC skills.
7. Demonstrate strong PC skills.
展示出較強(qiáng)的計(jì)算機(jī)操作技能。
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工作地點(diǎn)
遠(yuǎn)洋國(guó)際中心
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