10h ago

Senior Manager, Medical Writing

United States - Remote

$170.2k-$210.2k / year

full-timesenior Remotebiotech

🛠 Tech Stack

💼 About This Role

You'll lead the development of clinical and regulatory documents for a rare disease biopharma company. You'll drive cross-functional collaboration and distill complex data into clear messaging. This role offers a remote-first culture and the chance to impact patient lives.

🎯 What You'll Do

  • Author and edit clinical and regulatory documents
  • Coordinate cross-functional reviews and feedback resolution
  • Ensure compliance with ICH/GCP and regulatory guidelines
  • Contribute to department process improvements

📋 Requirements

  • BS/MS in scientific or medical field
  • 5+ years medical writing in biotech/pharma
  • Experience with clinical regulatory documents
  • eCTD submission experience preferred

✨ Nice to Have

  • Rare disease experience
  • Proficiency with Veeva Vault, StartingPoint, EndNote, Smartsheet, AI tools

🎁 Benefits & Perks

  • 🏖️ Generous vacation and public holidays
  • 📈 Long term incentive and stock purchase plans
  • 💪 Employee wellbeing benefits
  • 🏋️ Fitness reimbursement
  • 📚 Tuition sponsoring and professional development

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

  1. 1Recruiter Screen· 30 min
  2. 2Hiring Manager Interview· 60 min
  3. 3Technical/Cross-functional Interview· 60 min
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