Director of Medical Writing & Regulatory Submissions

Dren Bio, Inc. is seeking a Director/Senior Director of Medical Writing to provide strategic and operational leadership across oncology and autoimmune programs, delivering regulatory and clinical documents for global submissions.
The role partners with Clinical Development, Biostatistics, and Regulatory Affairs to ensure timelines and quality. You will lead a team and manage vendors, ensuring FDA/ICH compliance and high editorial standards for NDA/MAA submissions, protocols, CSRs, and

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