Senior Director, Medical Writing & Submissions (Remote)

Dyne Therapeutics; United States; On-site; USD 190,000 - 235,000; Full time

Job summary

Dyne Therapeutics is seeking a Director of Medical Writing to provide leadership in developing compliant clinical and regulatory documents. This role involves collaboration across various departments to ensure scientific messaging and document quality for FDA submissions.

The ideal candidate will have 10+ years in medical writing, exceptional communication skills, and proficiency in Microsoft Office and SharePoint. The pay range for this role is between $190,000 - $235,000 USD, reflecting the company's commitment to fair compensation.

Qualifications

• 10+ years of medical writing experience in pharmaceuticals or biotech.
• Deep experience in authoring and reviewing clinical documents.
• Strong understanding of FDA regulations and ICH guidelines.

Responsibilities

• Lead the planning and completion of clinical and regulatory documents.
• Manage medical writing resources to deliver accurate documents.
• Establish and improve medical writing processes and templates.

Skills

Medical writing

Regulatory submissions

Communication skills

Project management

Biochemistry principles

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat

SharePoint

Job description

Dyne Therapeutics is seeking a Director of Medical Writing to provide leadership in developing compliant clinical and regulatory documents. This role involves collaboration across various departments to ensure scientific messaging and document quality for FDA submissions.

The ideal candidate will have 10+ years in medical writing, exceptional communication skills, and proficiency in Microsoft Office and SharePoint. The pay range for this role is between $190,000 - $235,000 USD, reflecting the company's commitment to fair compensation.