(ID61947)高级医学事务经理-妇科 (职位编号：61947)招聘_上海任仕达人才服务有限公司最新招聘信息-猎才医药网

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职位描述： ?高级医学事务经理-妇科工作地点：上海工作职责：Medical Governance: To ensure Health Care Compliance on promotional material and Health Care Professional qualification in accordance with J&J policy, company GOP/SOP and related working procedure.To 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.MIR: To provide scientific and medical information to internal and external customers, including unsolicited requests from healthcare professionals, to ensure clinically appropriate and safe use of company products.Safety Vigilance: To work with other stakeholders as a team to ensure 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. Evaluate and submit the reportable Adverse Events to the competent Health Authorities in compliance with the company’s procedures and the local regulations. Keep good documentation on Adverse Event reported to the competent Health Authorities.To provide medical strategic plans and solutions to support business team on product and/or procedure management for related therapeutic area, in terms of evidence generation plan and proposal, evidence publication and dissemination, and other related activities.To collect investigators’ proposals (IIS) for local and regional clinical activities，to ensure that these proposals are discussed within the local clinical trial review committee, to coordinate Global Franchise approval processes, and to provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after IIS approval.To develop and maintain professional relationship with external experts, in accordance with the company strategy to further understand and gain both insight and/or input into treatment patterns，including the scientific activities taking place within the disease area，and the needs and behaviors of healthcare professionals.To provide strategic medical support to the clinical research operation team on medical activities relating to the conduct of a trial or survey，e.g. protocol preparation, safety review, study report writing and publication. Maintain scientific contacts with local investigators.To partner with other functional stakeholders, to prepare Clinical Evaluation Report to support product registration.To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation, if applicable.Other responsibilities defined in written procedures.（流程中规定的其它职责）Principle Relations (inside & outside company) 主要工作关系 (公司内部和外部)– Clinical research team in China, regional, global and source companies;– Medical affairs team in China, regional, global and source companies– Regulatory affairs team in China, regional, global and source companies– Quality assurance team in China, regional, global and source companies– Clinical Quality Control/Assurance team in China, regional, global and source companies– Business team, incl. marketing, sales, ProfEd and training;– R&D team in China, regional and source companies– Finance business partners;– Professional Education team;– Health Care Compliance team– Clinical research organizations, global, regional and local– Key opinion leaders and investigators– China health authorities, incl. China and provincial food and drug administrations2. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）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 4 years’ experience practicing medicine or products develop experience.– Industry experience in pharmaceutical marketing, clinical operation, or medical affairs would be preferred.– Good communicate skills in English, both orally and in writing.– Having good co-operation abilities and a positive character.Required Competencies 胜任能力要求 (Level 1- 4, see Appendix A)– Clinical trial expertise 4– Statistics & data analysis 3– Disease area knowledge 4– Regulatory insight 4– Product/Procedure/Therapeutic area knowledge 4– Scientific presentation & publication 4– Customer & market insight 3– Managing customer & internal partners 4– Cultural diversity 3– Project Management 3 职能类别：医药技术研发管理人员

公司信息

任仕达集团(Randstad Group) 成立于1960年，是全球最大的综合性人力资源服务机构之一，总部位于荷兰阿姆斯特丹。在全球40多个国家和地区设有4700多个分支机构，每天为57万名求职者提供工作岗位。2011年，其全球营业额达到162亿欧元，位列全球财富500强。任仕达自2005年进入中国市场，总部设在上海，在华北、华东、华南等地区成立了多个分支机构，服务网络覆盖全国100多个一、二线城市，向企业提供包括搜寻与甄选、灵活派遣以及人力资源解决方案在内的全方位人力资源服务。作为一家充满活力的专业招聘机构，任仕达始终坚持以人为本，不断追求创新。我们寻找才智过人、诚实可靠、胸怀抱负的求职者，把他们推荐给最适合的企业，帮助他们获得最具吸引力的薪酬和工作机会。无论您是想拓宽职场发展之路，或是寻找正确的职业发展方向，我们的招聘顾问都会随时为您提供服务。有了我们的协助，美好职业志在必得。想了解更多详情，请登录任仕达中国网站www.randstad.cn，或在新浪微博上@任仕达，与我们互动。 www.randstad.cn

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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