Senior Director, Medical Writing & Regulatory Submissions

HW3; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

A prominent biotech company in the United States is seeking a Senior / Director-Level Medical Writing Leader. This pivotal role involves leading writing strategies, overseeing critical regulatory and clinical documents, and collaborating with multiple departments. The ideal candidate will possess an advanced degree and over 8 years of medical writing experience in biotech/pharma. This position offers a chance to influence program strategies and thrive in a lean, collaborative environment.

Qualifications

• 8–10+ years of medical writing experience in biotech/pharma.
• Strong regulatory writing experience across clinical development and submissions.
• Deep understanding of ICH guidelines, FDA/EMA expectations, and GCP/GPP.

Responsibilities

• Lead medical writing strategy and execution across development programs.
• Author and oversee regulatory and clinical documents.
• Manage the full document lifecycle from planning to submission readiness.
• Support health authority interactions and oversee external writing vendors.

Skills

Medical writing experience

Regulatory writing expertise

Leadership capabilities

Cross-functional collaboration

Education

Advanced degree (PhD, PharmD, MD or similar)

Job description

A prominent biotech company in the United States is seeking a Senior / Director-Level Medical Writing Leader. This pivotal role involves leading writing strategies, overseeing critical regulatory and clinical documents, and collaborating with multiple departments. The ideal candidate will possess an advanced degree and over 8 years of medical writing experience in biotech/pharma. This position offers a chance to influence program strategies and thrive in a lean, collaborative environment.