Director, Medical Writing – US Biotech | Remote or Hybrid (East Coast Preferred)

Biotech | Oncology-Focused | Hands-On Writing with Growth into Leadership

Base Salary: $200K–$250K + Bonus + Equity

We're working with a fast-growing, US-based biotech that’s advancing a robust oncology pipeline. This is a high-impact, hands-on medical writing role at the Director level, suited for a seasoned professional who thrives on producing high-quality regulatory documents and is looking to evolve into a leadership position as the company scales.

The Opportunity

This is not a purely oversight or strategic position—you’ll be the lead writer responsible for crafting core clinical and regulatory documents (think protocols, CSRs, IBs, CTD summaries, and submission documents). You’ll work closely with clinical, regulatory, and development teams across the business and play a central role in shaping writing strategy and ensuring high-quality submissions globally.

As the company expands, you’ll also have the chance to build and mentor a small writing team, manage external vendors, and help define best practices and SOPs across Medical Writing.

Key Responsibilities
• Take the lead on authoring key clinical regulatory documents for global filings (IND, NDA, MAA, etc.)
• Drive timelines and ensure consistency across documents in collaboration with cross-functional teams
• Serve as a point of contact for medical writing in regulatory and clinical development discussions
• Mentor junior writers and help expand internal writing capabilities
• Contribute to writing processes, templates, and inspection readiness

Ideal Profile
• 8+ years of experience in medical writing within biotech/pharma, ideally including global submissions
• Strong background in writing IND/NDA/MAA-related documents
• Comfortable operating in a small, agile environment—hands-on and proactive
• Therapeutic area experience in oncology, immunology, or neurology preferred
• Experience with Veeva Vault, Smartsheet, and other common platforms a plus
• PhD or equivalent advanced degree preferred, though strong writers with a Master’s and extensive experience are encouraged to apply

Why This Role Stands Out
• Hands-on ownership: Not just oversight—you’ll write, shape, and drive submission documents
• Path to leadership: As the company grows, so will your team and strategic responsibilities
• High visibility: You’ll work directly with senior leadership in regulatory, clinical, and program development
• Mission-driven company: Impactful pipeline, patient-focused culture, and well-funded

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