Worldwide Clinical Trials
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
Regulatory & Site Activation Specialist
🔥 0 minutes ago
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Worldwide Clinical Trials
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
📋 Description
• Liaise with SAR colleagues to plan, organize, compile, progress, track, and submit regulatory submissions on time and with consistently high quality • Act as a contact point for translation review of submission documents, including applications, synopses, ICFs, and labels • Maintain country-specific patient information sheet and consent form customization text • Maintain country-specific drug labeling information and Country Intelligence Pages • Review relevant documentation, including labels, patient information sheets, and diary cards, and recommend changes to comply with ICH GCP and country-specific requirements • Initiate and develop relationships with local investigators and key site personnel
🎯 Requirements
• 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 • Organizational and time management skills • Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing • Strong written and verbal communication skills in English and local language • Ability to handle multiple tasks in a fast-paced and changing environment • Proficiency in Microsoft Word, Excel, and PowerPoint • Strong understanding of country-level cultural norms and local healthcare systems • Multilingualism preferred
🏖️ Benefits
• Equal employment opportunities • Diverse and inclusive work environment • Supportive and collaborative teams • Accessible leadership • Employee experiences where everyone is respected and has access to equal opportunity
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