Submission Strategy Lead

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🔥 3 hours ago

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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

• Serve as the regional submission strategy, governance, and submission risk management lead • Act as subject matter expert in clinical trial submission requirements and operational regulatory implementation • Drive strategic submission decisions and build submission plans and timelines • Monitor critical path activities and proactively identify and escalate risks, issues, delays, and trends across the study portfolio • Contribute to submission governance, quality governance initiatives, and continuous process improvement

🎯 Requirements

• Bachelor’s degree (or equivalent) or higher in a scientific, clinical trial, medical, or healthcare discipline • Minimum of 5 years of experience in clinical operations, study start-up, or regulatory affairs • Experience in biotech, pharmaceuticals or a related field in the biotech/pharmaceutical industry is essential • Good to Intermediate knowledge of Microsoft Word, Excel, PowerPoint, SharePoint, Microsoft Teams, and Outlook • Demonstrates working knowledge of Clinical Trial Management Systems • Fluent in written and verbal English • Strong interpersonal skills, can-do attitude, and problem-solving skills • Able to multi-task and meet compressed timelines.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development

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