Senior Medical Writer

🚨 Now Hiring: Senior Medical Writer (Oncology) – Remote | US-Based 🚨

Excited to partner with an innovative oncology-focused biotech seeking an experienced Senior Medical Writer to support a 12+ month remote contract engagement supporting clinical development programs.
If you thrive in fast-paced, collaborative environments and enjoy owning high-impact regulatory and clinical documents — this could be a fantastic next step.

✨ What You’ll Do:
• Lead preparation of key clinical & regulatory documents (Protocols, IBs, CSRs, DSURs, IND/NDA/MAA submissions, briefing books)
• Partner cross-functionally to plan document strategy & timelines
• Ensure scientific clarity, consistency, and regulatory compliance across programs
• Facilitate document adjudication meetings & drive alignment across stakeholders
• Manage review/approval workflows with internal teams and development partners
• Collaborate across global, cross-functional teams in a highly visible role

✅ What We’re Looking For:
• 8+ years Medical Writing experience within biotech/pharma or CRO
• Strong oncology drug development experience (required)
• Proven success supporting global regulatory submissions
• Expertise authoring protocols, IBs, DSURs, and IND/NDA/MAA CTD documents
• Advanced degree in Life Sciences preferred

📍 Location: Remote (Must be located in the United States)
📅 Duration: 12+ month contract
🧬 Therapeutic Area: Oncology

If you or someone in your network would be interested, I’d love to connect — feel free to message me directly or share with your network!

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⚠️ Please DO NOT APPLY if you cannot demonstrate relevant experience in the key areas listed above or meet the location requirements. 

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