💼 About This Role

You'll lead the development of complex clinical and regulatory documentation for oncology drug programs. Your core impact will be shaping strategic medical writing initiatives that support global regulatory submissions. This role offers a science-driven environment where you'll mentor writers and drive operational excellence.

🎯 What You'll Do

• Lead planning and authoring of clinical and regulatory documents
• Oversee preparation of CTD/eCTD summaries and submission materials
• Serve as medical writing representative on cross-functional teams
• Guide and mentor internal writers and vendors
• Drive development of medical writing processes and SOPs

📋 Requirements

• Bachelor's degree in a scientific discipline required
• 12+ years of clinical/regulatory medical writing experience in biotech/pharma
• Oncology experience is required
• Proven expertise leading major regulatory submissions (NDA, BLA, MAA)

✨ Nice to Have

• Advanced degree preferred
• Experience developing operational processes and mentoring teams

🎁 Benefits & Perks

• 💰 Competitive salary range $198,240–$297,360 annually
• 🏥 Comprehensive medical, dental, vision insurance
• 💼 401(k) match up to 6% of contributions
• 🏖️ 12 weeks paid parental leave + paid vacation and holidays
• 📚 Tuition reimbursement and lifestyle spending account

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 1 hour
3. 3Panel Interview· 2 hours
4. 4Offer· 1 week