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国际业务部实习生

150元/天

广东天普生化医药股份有限公司 查看所有职位

广州  |  无需经验  |  本科  |  招1人  |  09-17发布

职位信息

1.Cross-functional
communication and cooperation

? Assist the document preparation for feasibility analysis and the approval process of project initiation

? Responsible for the internal approval process of registration dossier

? Responsible for the preparation and delivery of registration samples as per the requirement of oversea authorities (or partners)

? Responsible for internal coordination work related to audit / inspection from overseas customers and/or authorities

? Assist the development and maintenance of departmental SOP

Other
cross-functional cooperation work

2.Dossier development and maintenance
? Responsible for the collection, translation and proofreading of the product related source data (in Chinese)

? Assist the sorting, analysis and summarization of the registration related data.

? Responsible for the notarization and apostiling of necessary administration documents for registration

? Responsible for the orderly management of international common documents for overseas registration of company products

Assist regularly
update the dossier in aspects on Quality, Non-clinical, Clinical parts.

3.Project
management on overseas submission

? Assist project management on overseas submission in delegated country, including international cooperation initiative, documents completed and dossier applications, review and approval tracking per the planning registration timeline and each milestone.

Responsible for
planning, organization, coordination and management some offshoot project,
which may be required in the process of the registration project progress in
specified country, such as tasks related to overseas GMP audit / inspection,
animal experiments, overseas clinical trials, etc.

4.External communication and coordination on
projects
Assist
the communication with external partners to ensure overseas registration
progress smoothly, following up the official review progress, timely to seek resource
to solve the problems if defects found and prompt to provide the solutions to
senior management when necessary.

5.完成上级主管指派的其他工作

遵守公司的相关制度或流程规定,包括但不仅限于业务流程、政策、工作纪律准则等;

遵守行业相关标准如GMPEHS等;


we prefer:
-University
degree or above in science aspect, preferably pharmaceutical English,
pharmaceutical regulations, pharmaceutical management, pharmacology, clinical
pharmacy, medicine science, or related field
-good command of Microsoft Word, Excel and PowerPoint

-good command of English

 -good communication and coordination capability

职能类别:其他

联系方式

上班地址:**

公司信息

作为上海医药集团的成员公司之一,广东天普生化医药股份有限公司成立于1993年,总部位于广州东部智慧城核心区,占地面积50000平方米,是一家专注于生物医药研发、生产和营销的生物制药公司。凭借着优秀的企业文化和完整的人才培养体系,2018、2019及2020连续三年荣获由杰出雇主调研机构颁发的 “中国杰出雇主证书 ”。

天普药业一直致力于在危重症领域成为值得尊敬和合作的生物医药的领军者,拥有美国发明专利1项,国家发明专利35项。2016年,入选工信部“中国生物制药企业百强”榜单并荣列第4位;2017年,荣膺由国家卫计委药政司颁发的“医药创新奖”。连续几年被中国医药工业信息中心评为“中国医药工业最具投资价值企业10强、最具成长力企业10强”。

天普自成立之初一直秉持自主研发、创新驱动的发展战略。自主创新是天普发展的重要核心竞争力,从拥有自主知识产权的蛋白质分离纯化技术,到国家一类新药凯力康?的上市,以“急危医谈”互联网公众平台为代表的创新推广模式,天普从技术创新、产品创新和推广模式等多个维度推进创新发展战略。

目前,天普主要产品有天普洛安?、凯力康?。天普洛安?(注射用乌司他丁)是国家二类新药,主要用于急性***炎、慢性复发性***炎及急性循环衰竭的治疗。天普洛安?填补了国内空白,使中国成为世界上第二个拥有该药物的国家。自 1999 年以来,总产量已超过1亿支,天普洛安?已救治超过 700 万名患者。凯力康?(注射用尤瑞克林)是国家一类新药,主要用于轻-中度急性血栓性脑梗死的治疗,是具有划时代意义的全球首创新药。自 2005 年上市,凯力康?在神经内科领域被临床所认可,获得多个中国卒中权威指南的推荐。

天普协同上海医药共同推进国际化发展战略,促进生物医药产业的国际化发展。同时国际化也是天普发展战略的重要组成部分,近两年,天普的国际化进程发展迅速,随着国家一带一路规划的战略部署,天普的产品以及原材料也出口至相应的沿线国家和地区。
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