Associate Director, Medical Writing
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Author, review, and manage clinical and regulatory documents including:
- 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.
Requirements
- 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
- Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus.
Benefits
- Clinical Study Protocols and Amendments
- Investigator Brochures
- Clinical Study Reports (CSRs)
- Regulatory submission documents (e.g., INDs, NDAs, MAAs)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory submissionsdocument managementtemplate developmentstyle guide creationeditingproject managementattention to detailbiotech experiencepharmaceutical experience
Soft skills
collaborationmentoringindependenceflexibilityadaptabilitycommunicationteam coordinationtime managementproblem-solvingorganizational skills
Certifications
PhDPharmDMS