南京招聘

? Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
? Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
? Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
? Coordinates submission publishing with offsite publishers/provides notification to ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues
? Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
? Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
? Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
? Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
? Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
? Position accountability/scope:
o Supervision required
o Receives project assignments from manager but has responsibility for managing own projects with oversight
o Reviews project progress with manager on a regular basis with direction provided by manager
o May assist with onboarding staff.


Bachelor’s degree
Note: Years of experience may also compensate for lower education.
PMP and RAC certificates desirable.
2-3 years pharmaceutical or industry related experience
Experience working in a complex and matrix environment
Strong communication skills both oral and written
Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
Proven leadership skills and presence
NOTE: Higher education may compensate for years of experience.

关于艾伯维中国

艾伯维（纽约证交所:ABBV）是一家于2013年1月2日正式成立的全球研究型生物制药公司，从雅培公司拆分而来。 艾伯维将尖端生物科技与百年传承的专注、激情，以及专业技术和组织架构集于一身，凭借其专业技术、敬业的员工和独特的创新方式，旨在研发并推广先进治疗方法，解决世界范围内的一些疑难杂症。2013年，全新成立的艾伯维在全球范围内拥有近21,000名员工，产品销往170多个国家。

艾伯维已在中国正式注册成为一家外商独资的医药公司,并且于2013年6月1日完成与雅培中国的拆分。艾伯维中国的产品线涉及多个疾病领域，涵盖免疫学领域、抗病毒学领域、肾脏学领域以及麻醉学领域。同时，艾伯维与中国的医学界和政府部门紧密合作，共同开展覆盖丙肝、肿瘤、免疫学、神经科学、疼痛和妇科健康等领域的临床研究。

艾伯维中国介绍

中国总部    上海

研发中心    艾伯维中国研发中心——上海张江研发中心，落成于2009年3月，是艾伯维全球7个研发中心之一。作为临床前研究的一环，支持全球药品研发中心（GPRD）的药物研发，主要集中在免疫、疼痛、神经系统与肾病领域。

员工数    近500名

历史 艾伯维中国成立于2013年6月1日

企业评级

艾伯维被纳入标准普尔500红利经典指数（S&P 500 Dividend Aristocrat Index） ，纳入这一指数的标准是公司股票连续25年以上实现持续增长的现金分红。同时， 艾伯维也被纳入标准普尔高产红利经典指数（S&P High Yield Dividend Aristocrats Index） ，纳入这一指数的标准是连续20年以上实现持续增长的现金分红。

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