Regulatory & Site Activation Specialist - Taiwan- Remote
我们是谁？我们是一个全球中型 CRO,跨越界限，创新和发明，因为世界上最持久的疾病治疗方法不是那些玩得安全的人铺平的。它是由那些采取先驱，创造性方法并以质量和卓越的方式实施的人建立的。我们是世界范围内的临床试验，我们是一支由3500多名专家，聪明思想家，梦想者和行为者的组成的全球团队，共同改变了全世界最佳方式体验 CROs.我们的使命是每天都用热情和目的努力改善生活，我们正在寻找其他重视这一追求的人。为什么在全球范围内 我们相信每个人都在为患者和他们的护理人员创造一个世界发挥重要作用。从我们的实践，可访问的领导者到我们团队，我们致力于让来自各个背景和经验的专业人士取得成功。我们优先培养一种多样化和包容性的环境，继续促进合作和创意。我们自豪成为一个工作场所，人们通过自己做出了好事并每天都能得到灵感。加入我们！全球监管部门做什么？我们的监管事务团队在药物开发过程的所有阶段都拥有北美和国际监管领域的实践知识。我们拥有丰富的行业经验，制定了各种监管要求的项目计划。我们的专家为客户产品策划最有效的路线，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提交申请，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，以及时制定计划，组织，编译，进展，跟踪和提供高质量的监管文件。·可以作为转化审查的接触点，例如申请，综述，ICF,标签等提交文件；·维护国家特定患者信息表和同意表格定制文本；维护国家具体药品标记信息和国家情报页面；·审查并提出有关所有相关文件的建议，如标签，病人信息表，日志卡等，以遵守 ICH GCP&c.
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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.
Originally posted on Himalayas