🛠 Tech Stack

💼 About This Role

You'll lead clinical and regulatory document preparation for a biotech company advancing novel biologics. You will collaborate with cross-functional teams to produce high-quality submission-ready documents, ensuring compliance and consistency. This role offers the chance to shape medical writing processes and leverage AI-enabled tools for efficiency.

🎯 What You'll Do

• Prepare, review, and edit clinical and regulatory documents (protocols, IB, CSRs).
• Communicate deliverables and timelines to cross-functional teams.
• Ensure compliance with regulatory guidelines and industry best practices.
• Manage medical writing projects by external vendors and consultants.

📋 Requirements

• Bachelor's in science with 8+ years of medical writing experience in pharma/biotech.
• Ability to analyze and interpret complex data accurately.
• Proven project management and organizational skills.
• Proficient in scientific writing tools (Microsoft Office, document management systems).

✨ Nice to Have

• Advanced degree (MS/PhD) in life sciences.
• Experience with AI-enabled writing tools.
• Experience mentoring junior writers.

🎁 Benefits & Perks

• 💰 Competitive base salary plus performance bonus and equity.
• 🏖️ Three weeks PTO plus two company-wide shutdowns.
• 💼 Health, welfare, and retirement benefits.
• 📈 Professional development opportunities.
• 🤝 Regular in-person team meetings.

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 60 min
3. 3Technical/team interview· 60 min
4. 4Final interview with director· 45 min