长沙招聘

1. Medical Affairs (60-70%): Responsible for building effective interfaces with marketing and maximum support to commercial teams to achieve business objectives. Compliance with internal and external applicable policies, procedures and other regulations.
2. Clinical operation (40-30%): Responsible for effectively managing and monitoring clinical trials and delivering on time and within budget. Provide input to top management teams to support strategic clinical trial decisions.

Major Responsibilitites

Medical Affairs (60-70%):
ü Develop product medical strategy and ensuring close co-operation with marketing and alignment with global and regional strategy.
ü Provide broad and deep understanding of the therapeutic area cross-functionally. Seen as credible medical and scientific expert by internal and external customers.
ü Actively ensure quality of study protocols, reports, summaries and publications from Post Market Studies. Ensure medical publication planning is tracked accurately and updated timely in Data vision.
ü KOL Development and Management: Develop and support together with medical marketing peers for external contacts (KOLs, influencers, and key external customers investigators, academic and regulatory community).
ü Responsible for final approval of all promotional items/events, ensuring local adherence to Novartis requirement (NP3, NP4) and local regulations.
ü Besides China mainland, support other GCK regions based on requirements especially for new product launch.

Clinical Operations (40-30%):
ü Responsible for effectively managing and monitoring clinical trials for assigned projects ensuring a high standard and delivering on time and within budget.
ü Identification and selection of investigators and vendors (e.g.CROs, Central Lab) to undertake clinical studies.
ü Ensures clinical trial data accuracy, timely recruitment of patients and smooth running of subsequent operations including data flow, database lock, statistical reporting, delivery of final study report within timelines and budget to GDRA
ü Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
ü Ensure all activities related to clinical study in compliance with Regulatory requirements, GCP guideline & NCH SOPs. Provide input in issuing and revision of appropriate NCH SOPs
ü Accountable for the discussion of allocates budget /resources and investments according to organizational/project priorities

Key interfaces:
- Global Medical Affairs, CRO Manager, Clinical Research & Biostatistics, Clinical Operations
- Global project team members: GRA, Pharmaceutical Research and Design, Quality Assurance, Pharmacovigilance, Project Managers and others
- CROs and study sites
- China State Food & Drug Administration (SFDA)
- China Centre for Drug Evaluation (CDE) of SFDA

Education:
Medical/clinical bachelor degree or higher

Languages:
Fluent in both Chinese and English (oral and written).

Experience:
1. Strong knowledge of the market preparation and access requirements, encompassing medical strategies and market trends
2. Strong interpersonal, communication, negotiation, and presentation skills.
3. Expert in all aspects of clinical drug development including experience designing and/or executing clinical studies to address local needs.
4. Successful development and implementation of innovative programs and processes.
5. Familiar with respective health authority, GCP and ICH requirements, including regulations of Promotional materials.
6. Proven ability to lead and coach scientific/medical personnel at all skill and knowledge levels.
7. Professional respect and credibility with extensive knowledge of therapeutic area, encompassing business strategy and market trends.

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。