天津招聘

To be the expertise in and knowledge of products，patient treatment trends，clinical
trials and scientific activities within the disease area and must continuously update
this expertise and knowledge.
Ensure promotional materials to be accurate, fair and objective and in compliance
with local regulations, scientific and ethical standards, HCC policies and ICH GCP.
Ensure the qualification of Health Care Professional by evaluating the authenticity
and accuracy of KOL’s Curriculum vitae.
Ensure the contents and medical claim in following parts of IFU, including Indication,
Contraindication, Potential complications, clinical trial related contents, Caution &
precaution and Adverse event, are accurate, fair and objective.
Provide evidence-based medical information, clinical evaluation, publication support,
professional trainings and presentations or any other value-added programs in a
certain area per requests from internal or external customers.

Prepare medical letter to address unsolicited requests from healthcare professionals
for information on the efficacy and safety of all marketed products in China.
Work with appropriate JJMC personnel to guarantee that all the information regarding
Adverse Events in the field is collected to facilitate a correct and transparent
communication of Adverse Events internally, and properly review the Adverse Events
and submit the reportable Adverse Events to the competent Health Authorities in
compliance with the company’s procedures and the local regulations.

Collect and medical device safety vigilance information regarding either JJMC
products or competitor’s products, from public resource regularly, evaluate and share
it with Franchise marketing team.
Assist in collection of investigators’ proposals for local and regional clinical
activities，ensure that these proposals are discussed within the local clinical trial
review committee，manage Asia Pacific and Global Franchise approval processes，
and provide timely feedback to investigators.
Assist in protocol and CRF design in a JJMC-sponsored clinical trial.
Develop an understanding and competence of SOPs，ICH/GCP，as well as ethical
standards.
Build up and maintain healthy relationships with internal customers and external
experts.
Take on any other task as assigned by line-manager/medical affairs manager.

Required Competencies 胜任能力要求 (Level 1-4, see Appendix A)

？ Clinical trial expertise 1
？ Statistics & data analysis 1
？ Disease area knowledge 2
？ Product/Procedure/Therapeutic area knowledge 2
？ Scientific presentation & publication 1
？ Customer & market insight 1
？ Managing customer & internal partners 1
？ Cultural diversity 1
？ Project Management 1
Personal requirements ( include experience, knowledge，skills and education)
个人背景要求 （包括经验，知识，技能和教育背景）

？ At least master degree of medicine，bioengineering or life science
？ At least 3 years experience practicing medicine or product develop experience
？ Industry experience in pharmaceutical marketing，clinical operation，or medical affairs
would be preferred.
？ Be able to communicate in English，both orally and in writing.
？ Good presentation skill
？ Having good co-operation abilities and a positive character.

        Fountain Medical Development Corp. is a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China. The management team of Fountain has decades of combined experience working with the world's leading CRO's and drug developers. In the Chinese CRO market, we fill the void of a service provider that balances high quality with moderate cost. Our extensive global experience in multiple therapeutic areas is unmatched by other local CRO's, and our lower operational cost allows us to pass significant savings on to our clients. www.fountain-med.com

    方恩医药是目前国内唯一一个，能够提供全方位与国际标准接轨的临床开发外包服务公司（CRO）。公司以天津为中心分别在北京、上海、香港、台湾及韩国建立了分支结构，并在香港和美国建立了实体公司，可以为国内外制药企业提供全程综合一站式服务，包括咨询服务、项目管理、注册服务，临床试验设计、EDC、中心实验室和Ⅰ、Ⅱ/Ⅲ及Ⅳ期临床试验服务。公司设有行政部、商务发展部、注册部、医学部、Ⅰ期临床试验中心、中心实验室、数据管理部等部门。各部门负责人均具有丰富跨国性临床试验经验及专业知识，在世界著名的CRO及制药企业组织完成过多项新药开发任务，与研究机构有着紧密联系，可为国内外客户提供非常专业的咨询服务。

    Ⅰ期临床试验中心可以开展药物耐受性、生物利用度/生物等效性及药代动力学等试验，Ⅰ期临床试验病房是目前国内最大的试验病房，配备国际一流水平的软硬件设施，执行电子化标准操作流程，所得临床试验数据支持在中国、美国以及欧盟进行药品注册，可以为您提供国际水平的Ⅰ期临床试验服务。

    医学部管理团队均在国际大公司工作过，在Ⅱ/Ⅲ期方案设计及管理方面有丰富的经验。拥有专业专职的临床监查员（CRA），均具有相关专业本科以上学历，接受过严格的GCP和SOP培训，并接受过国外大公司的项目培训及稽查，能严格遵守GCP和公司SOP。我们目前正在承担一个国际多中心临床试验。

    中心实验室以药物基因学（Pharmacogenomics）和生物标志物 (Biomarker)检测为特色，为您提供全方位的检测服务。实验室拥有的各种最先进的仪器设备平台能满足您的分析需求，如基因芯片、SNP分析，荧光定量PCR，蛋白质芯片、免疫分析，临床检验等。

    公司注册部拥有在药品、食品、医疗器械、诊断试剂等方面具有多年工作经验的专业的注册人员，可以为您提供注册咨询、注册全程服务。

    方恩医药团队是服务导向型的，我们会根据您的需求，为您提供量身打造的服务！