长沙招聘

1. Lead DRA Ops Officer/Publisher to be responsible for managing all aspects related to tracking, compilation, publishing and format quali-ty control of all assigned regulatory submissions. Ensure adherence to internal standards and processes, as well as Health Authority’s re-quirements on format and assembling.
a. Create and owns tracking sheet in REDI AA.
b. Initiate or attend submission kick-off meeting, introduce China submission management procedure and timeline.
c. Organize submission tracking meetings to follow up the availa-bilities and status of English/Chinese documents.
d. Ensure the completion of sign-off sheet after Line Functions review prior to submission.
e. Perform format quality check of the published dossier provided by the DRA Ops publisher.
f. Notify related LFs and DRA Project Manager the REDI link after publisher upload the electronic submission dossier and HA acknowledgement to REDI RR.
2. Provide expert advice and guidance to project teams regarding the format of regulatory submissions.
3. Manage the submission plan and coordinate for the resource alloca-tion.
4. Test and adapt global DRA tools/applications in China to optimize submission quality and work efficiency.
5. Submission dossier format management: educate translation vendors to meet the format requirements for Novartis submission dossier; manage submission dossier templates.
6. Version control of Chinese submission dossier: to minimize man-made mistakes and risks.
7. Compile DRA monthly report with updates from DRA Franchise Head and update the regulatory intelligence database in SharePoint.
8. Work closely with team to refine internal business processes to adapt to new operation model.
9. Maintain and support software applications and databases used within DRA. Provide training on xEDIs/TVT and DRA related applications, SOP and working process.
10. Execute daily operation compliance with DRA SoPs/ICC/ACC/NVS code/NP4.
11. Provide coaching to DRA Operation Officers.

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。

“诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。

诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。