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Dianthus Therapeutics, Inc. · 1 month ago

Associate Director, Medical Writing

United States

Full-time

Remote

Lead/Staff, Director/Executive

8+ years exp

Dianthus Therapeutics is focused on developing innovative therapies for severe autoimmune diseases. The Associate Director of Medical Writing will lead the creation of clinical and regulatory documents, ensuring compliance and clarity while collaborating with various teams to support drug development and regulatory submissions.

BiopharmaBiotechnologyHealth Care

Responsibilities

Author, review, and manage clinical and regulatory documents including:

Clinical Study Protocols and Amendments

Investigator Brochures

Clinical Study Reports (CSRs)

Regulatory submission documents (e.g., INDs, NDAs, MAAs)

Collaborate with internal teams and external vendors to manage timelines and deliverables

Provide input on document planning and regulatory submissions

Ensure documents comply with ICH guidelines, regulatory requirements, and company standards

Develop and maintain templates, style guides, and best practices for medical writing

Mentor junior writers and contribute to building the medical writing function

Qualification

Medical writingRegulatory submissionsICH guidelinesBiotech/pharmaceutical experienceProject managementStartingPoint templatesPleaseReviewMicrosoft ProjectCollaborationAttention to detailMentoringAdaptability