🛠 Tech Stack

💼 About This Role

You'll lead the writing of clinical and regulatory documents for a radiopharmaceutical company advancing cancer imaging and therapy. Your core impact is supporting global regulatory submissions for our approved prostate cancer agent and late-stage pipeline. This role offers the chance to work on precision medicine that improves patient lives.

🎯 What You'll Do

• Author clinical study reports, protocols, Investigator Brochures, and eCTD summaries.
• Interpret clinical data, literature, and statistics to compose regulatory documents.
• Collaborate with cross-functional teams (clinicians, statisticians) on submissions.
• Develop and maintain SOPs, templates, and style guides for medical writing.

📋 Requirements

• 5+ years of regulatory medical writing experience.
• Bachelor's in science or related field; advanced degree preferred.
• Strong knowledge of FDA/EMA/ICH guidelines and clinical study design.
• Experience with eCTD submissions and clinical regulatory documents.

✨ Nice to Have

• Experience in oncology or radiopharmaceuticals.
• Leadership or project management skills.
• Familiarity with document management systems.

🎁 Benefits & Perks

• 💰 Competitive salary and annual performance bonuses
• 📈 Equity-based incentive program
• 🏖️ Generous vacation and paid wellness days
• 📚 Learning and development support

📨 Hiring Process

Estimated timeline: 2-3 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Assessment· 60 min