💼 About This Role

You'll lead the preparation of clinical study synopses, minutes for advisory boards, and clinical sections of regulatory documents at a fast-growing radiopharmaceutical company. Your expertise in regulatory writing will support the international roll-out of a prostate cancer imaging agent and advance a portfolio of late-stage oncology products.

🎯 What You'll Do

• Lead compilation of clinical study synopses, advisory board minutes, and regulatory document sections.
• Interpret data and compose text based on scientific conclusions and literature analysis.
• Manage multiple medical writing projects ensuring timely delivery of high-quality documents.
• Coordinate with cross-functional teams to gather information and resolve issues during document development.

📋 Requirements

• Master's degree in a scientific or related field.
• 8+ years of regulatory writing experience including clinical development writing.
• Understanding of drug development, clinical study design, and FDA/EMA/ICH guidelines.
• Experience writing clinical study synopses, minutes, and clinical sections of regulatory documents.

✨ Nice to Have

• PhD preferred.
• Experience overseeing and mentoring contractors and junior team members strongly preferred.
• Proficiency with document templates, toolbars, and version control.

🎁 Benefits & Perks

• 🏖️ Flexible remote work
• 🏥 Health insurance coverage
• 💼 Professional development opportunities
• 🎯 Mission-driven work in radiopharmaceuticals