Senior Director Medical Writing

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

Hiring: Senior / Director-Level Medical Writing Leader (Biotech)

We’re partnering with a clinical-stage biotech to bring on a Medical Writing leader to support advancing development programs. This is a highly visible, hands‑on role with ownership across key regulatory and clinical deliverables.

What you’ll do:

• Lead medical writing strategy and execution across development programs
• Author and oversee critical regulatory and clinical documents (IBs, protocols, CSRs, IND/CTA components, summaries)
• Manage the full document lifecycle — planning, cross-functional review, QC, and submission readiness
• Partner closely with Regulatory, Clinical, Biostats, and Operations to align on program strategy and timelines
• Support health authority interactions (briefing books, responses, etc.)
• Oversee external medical writing vendors and ensure high-quality deliverables
• Contribute to process improvements, SOP development, and overall function build‑out
• Support global submission readiness (eCTD, NDA/BLA/MAA) and trial disclosure activities

What they’re looking for:

• Advanced degree (PhD, PharmD, MD or similar)
• ~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
• Proven ability to operate cross-functional in a fast-paced, evolving environment
• Leadership experience (team oversight and/or vendor management)
• For more senior candidates: prior ownership of major regulatory submissions

This is a great opportunity for someone who enjoys owning work end-to-end, influencing program strategy, and operating in a lean, collaborative biotech environment.

If this aligns, feel free to reach out directly.