Dianthus Therapeutics, Inc. · 1 month ago
Associate Director, Medical Writing
United States
Full-time
Remote
Lead/Staff, Director/Executive
8+ years expDianthus 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
Required
Advanced degree in life sciences (PhD, PharmD, or MS preferred)
8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions
Strong knowledge of ICH, FDA, and EMA guidelines
Excellent writing, editing, and project management skills
Ability to work independently in a fast-paced, start-up environment
Ability to work collaboratively and coordinate the efforts to resolve comments with team members
Flexible and able to adapt to changing deadlines and priorities
High attention to detail
Preferred
Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus
Company
Dianthus Therapeutics, Inc.
Dianthus Therapeutics, Inc.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$639.5M2025-09-09Post Ipo Equity· $288M
2024-01-22Post Ipo Equity· $230M
2023-09-12IPO
Leadership Team
Marino Garcia
President & Chief Executive Officer, Board Member
Ryan Savitz
Chief Financial Officer
Recent News
Clinical Trials Arena
2025-12-25
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