北京招聘

Job Purpose:
Responsible for leading the EC submission team for GCP office pre-review and EC submission Work with CSM/CRA/Contract/HGRAC responsible to shorten start up timeline.
Compliance with local regulations, GCP, Novartis SOP and applicable policies.

Your Key Responsibilities:
1. SSU Team Management
? Hire, train, and supervise SSU team and allocate tasks to appropriate specialist.
? SSU specialist workload evaluation and calculation
? SSU specialist’s on-boarding and hand-over process set up, including but not limited to hiring, training, hand-over report etc.
? Leads, inspires and develops staff to improve and maintain their individual performance
? Provides training and coaching to SSU specialists with regard to process.
? Supervise and make proper QC for SSU specialists’ work.
? Set up SSU work objectives and KPIs, and make them fully awareness for the objectives and KPIs.
? Regular work review with individual contract specialists to catch up and monitor work’s progression.
? Yearly performance review and evaluate and feedback to SSU specialist.
2. GCP office pre-review
? Work with CSM to setup start-up timeline
? Make sure the start-up timeline is delivered on track.
? Work with site selection CRA and deliver mandatory steps before EC submission at most sites
? Make sure central EC approval is done by site request.
? Set up a database for GCP office requirement
3. EC submission
? Make sure EC documents preparation in a timely manner.
? Monitor EC approval timetable to meeting study start up timeline.
? Set up a database for all the sites EC requirements
? Work with CRA/contract/HGRAC responsible to get all the RIS documents prepared in a timely manner.
4. Start-up timelines
? Communicate with internal and external stakeholders
? Start-up timeline set up and commitment and execution

Desirable requirements:
1. Education:
Degree in scientific or healthcare is preferred, or equivalent working experience
2. Languages:
Fluent English (Oral and spoken), Fluent in local language
3. Experience/Professional requirement:
? minimum 3 years pharmaceutical industry experience with 1+ years strong experience in study start up
4. Competencies:
? Proven ability to manage teams and complex communication locally and in the global organization.
? Able to work in a matrix organization
? Ability to work under pressure
? Strong Interpersonal skills
5. Skills & Knowledge
? Strong leadership skills
? Working experience in a global team, team player
? Displays innovative ideas and solutions
? Highly proficient in negotiation skills
? Highly effective in influencing others

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine

诺华（Novartis AG）是全球医药保健行业的领导者。其核心业务涉及专利药，非专利药，眼睛护理，消费者保健和动物保健等领域。诺华公司总部设在瑞士巴塞尔，业务遍及全球140多个国家和地区。

诺华（中国）生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所（NIBR）的第八个研究基地。我们位于中国上海市张江高科技园区，将成为诺华在亚洲的主要研究中心，以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法，用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段，研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验，进行安全性研究，生物标志物和检测分析，表达谱、生物分析以及转化医学的研究。

随着公司业务的迅速扩展，我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。