医学副总监/高级医学经理

面议

广州市

刷新时间：2024-02-27

职位描述

  Associate Director/ Sr. Medical Manager, is responsible for the development and execution of clinical trials, including but not limit to authoring key study documents (e.g., protocol, study charters, memos to sites), and monitoring and reviewing clinical trial data. Who also shall work with multiple functions to ensure the successful completion of the clinical trial within full compliance with global regulations.
医学副总监/高级医学经理负责临床试验的开发和执行，包括但不限于关键研究文件的撰写，以及医学监察和审查临床试验数据。且能与其他多部门合作，并确保在符合法规要求的情况下完成临床试验。
Responsibilities and Duties
岗位职责
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Pharmacology, and other relevant functions to design and execute clinical trials.
与临床运营，法规注册，统计，临床药理及其他相关部门合作设计临床试验。
• Work in collaboration with our Regulatory and Safety teams to ensure IND, protocol, ICF and other study and regulatory documents and reporting requirements are fulfilled.
与法规注册和药物警戒团队合作，完成包括IND文件、研究方案、知情同意书和其他研究或监管文件的撰写。
• Work in collaboration with Clinical Operations and Study Management Team (SMT) to assist in vendor selection and site selection, initiation, and ongoing medical monitoring.
与临床运营及临床研究管理团队合作完成供应商评估何选择，研究中心选择以及研究过程中的医学监察。
• Work to help resolve any key issues that may arise during clinical studies.
协助解决临床试验过程中的关键医学问题
• Help identify key opinion leaders for target indications, interact with PI. and help organize and prepare scientific advisory boards as needed.
协助确认目标适应症的KOL，与研究者建立联系，协助顾问委员会的组织。
• Serve as an internal clinical expert and participate in global development activities and meetings as a medical subject matter expert.
作为内部医学专家给予其他部门所需的医学支持

Qualifications:
任职要求
Basic
基本要求
• MD
医学博士学位
• Minimum of 2 -3years of clinical practice experience
至少2-3年的临床实践经验
Preferred Skills:
有以下经验或能力优先
• Subspecialty board eligibility/certification in Endocrinology, Orthopedics cardiovascular or immunology preferred.
内分泌，骨科，风湿免疫学，心血管背景优先
• Prior experience authoring, monitoring, analyzing, and presenting clinical trial related documents such as study concept documents, clinical trial protocols, investigational brochures.
既往有撰写临床试验相关文件（例如临床试验方案，研究手册）的先前经验优先，有分析研究，医学监察经验者优先
• Strong basic science or clinical research background in academia or biopharma industry work experience.
有基础研究和临床研究经验优先
有生物医药工作经验优先
• Knowledge of GCP, ICH, EMA/CHMP, and FDA policies
熟悉国内外法规及相关指导原则
• Excellent oral and written communication skills. Proficiency in English is a plus.
具有良好的口头表达和书面表达能力，需要有较好的英文水平，可顺利的与国外同事交流
• Ability to present ideas and complex medical/clinical concepts.
具有良好沟通能力，能较好的讲解复杂医学原理的能力
• Strong ability to work under pressure to ensure moving ahead projects smoothly.
有较强的抗压能力，可全力配合项目的全力推进。
• Previous experience in clinical trials and regulatory filings
既往有临床试验的设计,监察经验，参与过注册文件撰写优先
• Demonstrated ability to stay in trends with the latest information in the profession.
具有紧跟相应领域研究进展的能力
• Strong interpersonal skills and problem-solving abilities
• 具有良好的人际沟通能力和解决问题的能力
• Keen sense of responsibility and teamwork spirit, able to cooperate with colleagues from around the world.
具有责任心和团队合作精神，可以与来自国内外的同事通力合作  

其他要求

招聘人数：1人
职能类别：医学撰写

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。