BeOne Medicines
10,000+ employees
Founded 2010
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
Regional Clinical Compliance Manager
🔥 0 minutes ago
🗣️🇪🇸 Spanish Required
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BeOne Medicines
10,000+ employees
Founded 2010
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
📋 Description
• Ensure robust oversight of clinical trial compliance at the country and site level • Apply a risk-based approach to proactively identify, evaluate, and manage compliance risks • Serve as the primary point of contact for country teams regarding GCP requirements and company procedures • Analyze and confirm initial country and site-specific risks and identify high-risk sites • Conduct Site Compliance Visits on identified high-risk sites • Support country teams in identifying, managing, and resolving compliance issues • Support and manage individual Corrective and Preventive Actions (CAPAs)
🎯 Requirements
• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline • Minimum of 5 years of progressive experience in clinical operations roles • Minimum 4 years’ experience in a GCP compliance or equivalent role • Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines • Analytical and problem-solving skills • High attention to detail and quality orientation • Excellent English and Spanish written and verbal communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multitask • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
🏖️ Benefits
• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities
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