regulatory intelligence
丘以思（上海）医药信息咨询有限公司
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-07-06
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 职位月薪：1.3-2万/月
- 职位类别：药品注册
职位描述
职位描述：
岗位职责：
Job Purpose
A 3rd party position to support NVS internal RA team to optimize the use of regulatory intelligence in order to timely define regulatory strategic, project communications and internal operations.
Major accountability
1. Monitoring and search of CFDA relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferences, workshops and associations activities
2. Issue monthly China regulatory report (and alerts when necessary)
3. Coordinate to collect NVS internal comments on draft legislation/guidance and organize internal position about draft legislation/guidance in order to influence HA via interactions with Authorities and association, such as RDPAC and PhRMA
4. Monitor CDE backlog solving progress and key projects moving speed in CDE to support DRA planning and strategy adjusted;
5. Utilize external information from CDE website or provided by vendors about regulatory information (such as GBI, 丁香园), to support DRA team to setup internal data base for well planning and communications;
6. Coordinate other regulatory intelligence work assigned by GDD China RA office
7. Coordinate internal trainings to DRA colleagues about emerging regulatory requirements by or cross functionally and via written communication, such as newsletters, information e-mails etc.
8. Setup local DRA regulation data base in DRA SharePoint
Requirement:
1. Education: BS degree or above on pharmaceutical, medical or Bio science
2. language: Fluency in English as a business language, good written English will be a plus
3. Experience:handled registration project and familiar with CFDA drug registration regulation and process monitoring and search of relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferences,having people net with RA of industry
4. Personality: good at communication, open mind and team work spirt.
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岗位职责：
Job Purpose
A 3rd party position to support NVS internal RA team to optimize the use of regulatory intelligence in order to timely define regulatory strategic, project communications and internal operations.
Major accountability
1. Monitoring and search of CFDA relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferences, workshops and associations activities
2. Issue monthly China regulatory report (and alerts when necessary)
3. Coordinate to collect NVS internal comments on draft legislation/guidance and organize internal position about draft legislation/guidance in order to influence HA via interactions with Authorities and association, such as RDPAC and PhRMA
4. Monitor CDE backlog solving progress and key projects moving speed in CDE to support DRA planning and strategy adjusted;
5. Utilize external information from CDE website or provided by vendors about regulatory information (such as GBI, 丁香园), to support DRA team to setup internal data base for well planning and communications;
6. Coordinate other regulatory intelligence work assigned by GDD China RA office
7. Coordinate internal trainings to DRA colleagues about emerging regulatory requirements by or cross functionally and via written communication, such as newsletters, information e-mails etc.
8. Setup local DRA regulation data base in DRA SharePoint
Requirement:
1. Education: BS degree or above on pharmaceutical, medical or Bio science
2. language: Fluency in English as a business language, good written English will be a plus
3. Experience:handled registration project and familiar with CFDA drug registration regulation and process monitoring and search of relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority webpages and public databases, public conferences,having people net with RA of industry
4. Personality: good at communication, open mind and team work spirt.
职能类别： 药品注册
关键字： 注册
公司介绍
Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
联系方式
- Email：kding@clinipace.com
- 公司地址：地址：span广州