Specialist, Regulatory & Site Activation

🔥 5 minutes ago

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 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.

🎯 Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences • Minimum two 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, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research • Multilingualism preferred; fluent in local language; working knowledge of English. • Candidates must have strong experience in the regulatory process in Brazil to be considered for this role.

🏖️ Benefits

• Diverse and inclusive work environment • Accessible leaders • Supportive teams