南京招聘

*Job Description

1. Provide technical support to team members of Regulatory Affairs Department to ensure that they have the required knowledge to fulfill their duties, including training.
2. Provide overall supervision and guidance for Regulatory Affairs
3. Support for administrative works of Regulatory Affairs
4. Participate in and contribute to project bids, including client presentations.
5. Support the feasibility evaluation process from Regulatory Point of View.
6. Regulatory consultation
7. Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc.
8. Regulatory information collection and sharing
9. Regulatory and IRB-related submission and coordination, including initial submission, supplementary submission, amendment application and etc.
10. Archiving documents management if designated as an archivist
If designated as clinical trial submission coordinator
May be to perform the role of a Regulatory Lead in certain projects. When acting as a Regulatory Lead, the responsibilities will include the following in addition (project specific):
11. Provide the instruction to team for preparing the submission-required documents
12. Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled.
13. Highlight common issues and address these with the team as a training need.
14. Raise concerns with the Project Manager/Clinical Lead as appropriate

*Job Qualifications

1. Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company; detail oriented; strong written and oral communications skills, as well as excellent interpersonal skills; motivated to work consistently in a fast-paced and rapidly changing environment.
2. Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations at conferences, meetings, training sessions).
3. Team player with outstanding interpersonal, negotiation skills and organizational skills.
4. Demonstrated ability to manage and motivate direct reports.
5. Ability to role model behaviors and ethics in line with PAREXEL APEX Mission, Vision and Values.
6. Minimum three years experience in Regulatory Affairs
7 A bachelor (or above) degree BS in life sciences or pharmaceutical background or equivalent
8 Good communication in Fluent English

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。