Key responsibilities
Prepares, reviews and coordinates, under guidance, local regulatory submissions MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under mentorship local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under mentorship, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPD’s target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Keys to Success
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Knowledge, Skills and Abilities:
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good digital literacy and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
遗传办专员
8千-1.4万·13薪
北京-东城区
1年及以上
本科
全职
更新于04-21
收藏先聊聊
职位信息
工作地址
北京来福士中心应届生安全提醒
求职过程中如果遇到违规收费、信息不实、以招聘名义的培训收费或者微信营销等虚假招聘行为，请保留证据，维护自己的合法权益。谨防上当受骗！
公司信息
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries.
In order to meet the local needs in China, we have established 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.
赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon，为客户提供领先的创新技术、便捷采购方案和全方位服务。
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年，在中国的总部设于上海，并在北京、广州、香港、成都、沈阳、西安、南京、武汉、济南、东莞等地设立了分公司，员工人数约为5000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等，提供实验室综合解决方案，为各行各业的客户服务。
为了满足中国市场的需求，现有8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室，将世界级的前沿技术和产品带给中国客户，并提供应用开发与培训等多项服务；位于上海和苏州的中国创新中心，拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发，结合中国市场的需求和国内外先进技术，研发适合中国用户的技术和产品；我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队，在全国有超过2800名专业人员直接为客户提供服务。
我们致力于帮助客户使世界更健康、更清洁、更安全。
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries.
In order to meet the local needs in China, we have established 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.
赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon，为客户提供领先的创新技术、便捷采购方案和全方位服务。
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年，在中国的总部设于上海，并在北京、广州、香港、成都、沈阳、西安、南京、武汉、济南、东莞等地设立了分公司，员工人数约为5000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等，提供实验室综合解决方案，为各行各业的客户服务。
为了满足中国市场的需求，现有8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室，将世界级的前沿技术和产品带给中国客户，并提供应用开发与培训等多项服务；位于上海和苏州的中国创新中心，拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发，结合中国市场的需求和国内外先进技术，研发适合中国用户的技术和产品；我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队，在全国有超过2800名专业人员直接为客户提供服务。
我们致力于帮助客户使世界更健康、更清洁、更安全。
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赛默飞世尔科技（中国）有限公司
外资（欧美）
1000-5000人
多元化业务集团公司
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