Regulatory & Site Activation Specialist - Taiwan- Remote
职位标题：监管和网站激活专家 - 台湾-远程工作地点：虚拟台灣工作场所类型：远程工作合同类型：全日制工作资深级别：我们是全球中大型 CRO,跨越界限，创新和发明，因为世界上最持久的疾病的治疗路由那些玩得安全的人没有铺平。它是由那些采取先性，创造性的方法并以质量和卓越的方式实施者构建的。我们是世界范围内的临床试验，我们是一个超过 3,500+ 的专家，聪明思想家，梦想家和行为者的全球团队，共同改变了全世界最佳方式体验 CROs. 我们的使命是每天以热情和目的努力改善生活，我们正在寻找那些重视同样的追求的人。为什么全球 我们相信每个人都在为患者及其护理人员带来变化方面发挥重要作用。从我们的实践可靠领导者到我们的团队，我们致力于让来自不同背景和经验的专业人士取得成功。我们优先培养多元化的包容环境，继续促进合作和创造力。我们自豪地成为一个通过自我发展而成长并受到鼓舞的工作场所。加入我们！我们的监管部门在全球范围内拥有北美和国际监管领域的所有阶段的实践知识。我们拥有丰富的行业经验，以塑造各种监管要求的项目计划。我们的专家为客户制定了最有效的路线产品，从生物分析研究要求，与 FDA 进行前 IND/NDA 会议和向合格当局和伦理委员会申请，到成功营销应用程序，同时提供必要的指导来确保持续遵守监管。你将做什么？·与 SAR 同事进行联系，以及时制定规划，组织，编译，进展，追踪和提交监管文件，并保持高质量。·可以作为转化审查申请，综述，ICF,标签等提交文件的接触点；·维护国家特定患者信息表格和同意表格定制文本；维护国家具体药品标记信息和 Co.
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Job Title: Regulatory & Site Activation Specialist - Taiwan- Remote
Job Location: Virtual Taiwan
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Regulatory Affairs Department does at Worldwide
Our Regulatory Affairs team boasts practical knowledge in the North American and International regulatory arenas through all phases of the drug-development process. We hold extensive industry experience shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for our clients’ products, from bioanalytical study requirements, pre-IND/pre-NDA meetings with the FDA, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance.
What you will do
- Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality.
- May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc.
- Maintain country-specific patient information sheet and consent form customization text, Maintain country-specific drug labeling information and Country Intelligence Pages
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.
What you will bring to the role
- Organizational and time management skills
- Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Strong written and verbal communication skills to clearly and concisely present information in English and local language both
- Strong ability to handle multiple tasks in a fast-paced and changing environment
- Proficiency in MS Office applications, including Microsoft Word, Excel, and PowerPoint
- Strong understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
Your experience
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences
- Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function
- Previous experience within the pharmaceutical/CRO industry.
- Thorough knowledge of ICH GCP, and other relevant guidance on conducting clinical research.
- Experience in regulatory submissions in Taiwan
- Multilingualism preferred; working knowledge of English.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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Originally posted on Himalayas