🛠 Tech Stack

💼 About This Role

You'll lead the development of high-quality clinical study documents for a global CRO serving biotech. Your core impact is ensuring regulatory compliance and delivering documents like protocols and CSRs on time. You'll collaborate directly with sponsors and internal teams in a fast-paced, remote environment.

🎯 What You'll Do

• Write/update clinical study documents (protocols, IBs, CSRs).
• Perform quality control review of document content.
• Manage document lifecycle from template to final approval.
• Conduct literature research to support writing tasks.

📋 Requirements

• BS degree in a scientific or medical discipline.
• 5+ years of medical writing in sponsor or CRO setting.
• Proficiency in MS Office, Adobe Acrobat, and regulatory guidelines.
• Understanding of ICH, FDA, GCP, and eCTD requirements.

✨ Nice to Have

• Advanced degree (MS/PhD).
• Oncology or rare disease experience.
• Protocol and CSR development expertise.

🎁 Benefits & Perks

• 💰 Discretionary annual bonus
• 🏥 Health insurance
• 🏖️ Paid time off (sick/vacation)
• 👶 Parental leave
• 💼 Retirement savings benefits

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screening· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical/Writing Assessment· 60 min