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

Biotech | Oncology-reputed company | Hands-On Writing with reputed company into Leadership reputed company 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-reputed company, hands-on medical writing role at the Director level, suited for a seasoned reputed company who thrives on producing high-reputed company regulatory documents and is looking to reputed company into a leadership position as reputed company scales. reputed company This is not a purely reputed company or strategic position—you’ll be the reputed company reputed company responsible for crafting reputed company 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 reputed company and ensuring high-reputed company submissions globally. As reputed 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 reputed company 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 reputed company 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 reputed company biotech/reputed company, ideally including global submissions • Strong background in writing IND/NDA/MAA-reputed company documents • Comfortable operating in a small, agile environment—hands-on and proactive • Therapeutic area experience in oncology, immunology, or neurology preferred • Experience with reputed company Vault, reputed company, 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 reputed company—you’ll write, shape, and drive submission documents • reputed company to leadership: As reputed 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-reputed company culture, and reputed company-funded Apply Job! Apply to this Job