北京招聘

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)

爱的发制药集团是以研发为主导的国际化药物释放技术公司，公司拥有一系列的药物释放技术平台，可以满足从传统小分子到生物大分子递送的各种要求，基于其全球的5个研发中心和4个生产基地，62组全球性的专利保护，爱的发为客户提供从研发、注册到生产的全方位服务。
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。