医学事务总监
上海爱的发制药有限公司
- 公司规模:150-500人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-10-23
- 工作地点:上海
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:硕士
- 语言要求:英语熟练
- 职位月薪:4-5万/月
- 职位类别:生物工程/生物制药
职位描述
1. 隶属部门/Situation in structure
属总经理直接领导
Directly lead by GM
2. 职责/Mission
负责公司所有医学事务部门和医学临床试验相关工作
Be responsible for all Medical Affairs Department and all Medical, Clinical Trial related works of the company.
3. 主要工作/Main Activities
- Create the KOL network and attend key congress in China/abroad for the core products of the company
- Develop the medical and scientific knowledge for the affiliate and its main customers
- Coordinates the medical information in liaison with Ethypharm HQ and conducts training programs for internal/external audiences
- Support the commercial team to build new marketing/promotion tools and message
- Medical input for new projects evaluation
- Lead the clinical trials (specialty) and bioequivalence (generic) programs of the company
- Prepare detailed timelines and budget, and establish trials’ milestones
- Participate in study protocol writing
- CRO selection
- Identify (in conjunction with the selected CRO) high quality investigational centers to conduct the trials and conduct site visits as required
- Prepare and/or manage with the CRO the production of all the documents necessary to implement and monitor the trials
- Support the Regulatory Affairs (RA) in regard of their clinical documents submission
- Responsible for regular advancement reports
- Responsible for checking and accepting the study report to ensure it compliance with GCP and other relevant requirements in conjunction with Medical or PK department of Ethypharm HQ
- Responsible for collecting and reviewing the medical literature for the relevant products during the study
4. 任职要求/ Requirements
- Master of Medical degree with relevant clinical experience
- Fluent and proficient in English and Mandarin (writing / speaking) – French language as plus
- Chinese national (M/F) with preferred international exposure (studying, living or working)
- A minimum of 5 years’ experience in pharmaceutical / biotech industry
- experience in clinical trial management (depth therapeutic and protocol knowledge; ability to set up budget and control costs; CRO selection; relationship with clinical experts; familiar with applicable clinical research regulatory requirements such as GCP and ICH, etc...)
- Able to work independently on study planning and execution
- Must be willing to travel as required
- Excellent communication, negotiation and interpersonal skills
- Excellent team player with global mindset
- Recognized internally for medical expertise
- Ability to distil key messages to support their recommendation
- Prior experience working with Microsoft office products (Word, Excel, PowerPoint)
职能类别:生物工程/生物制药
公司介绍
目前,公司已经拥有超过1600项的市场授权,为50多个化合物开发了不同的配方,爱的发将产品授权客户,在70多个国家上市,包括诸多知名跨国公司在内的超过200家制药企业选择爱的发作为他们信赖和合作伙伴。
作为***批中法合作的制药企业,上海爱的发成立于1995年11月,基于其创新的药物释放技术,上海爱的发在中国开发和上市了一系列产品,并为客户提供包括可行性研究、工艺放大、临床实验、注册和工业化生产的全方位服务;作为中国药物释放产业的领军企业,上海爱的发通过提高现有产品的治疗效能和竞争力,帮助合作伙伴延长产品的生命周期和专利保护,而所做的提高和改进都达到或者超过生产规范国际标准的要求。
联系方式
- 公司地址:地址:span上海市青浦区前云路278号