Medical Writer

Trebla Talent; San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Trebla Talent is seeking a Senior Director, Medical Writing to build the function from the ground up in the Bay Area. You will establish infrastructure, standards, and processes while hands-on authoring key clinical and regulatory documents for its growing late-stage pipeline.

You will direct writing efforts, oversee internal and external authors and vendors, manage a budget, and ensure all documents meet ICH/FDA/EMA standards.

Qualifications

• 10+ years of medical writing experience.
• Experience managing a team of direct reports.
• Prior experience with quality, scientific/regulatory documents.
• Late-stage experience is required (NDA/BLA/MAA).

Responsibilities

• Direct authoring of critical documents.
• Build a scalable writing infrastructure, including budget and resourcing.
• Oversee internal and external authors/vendors on writing deliverables.
• Ensure documents meet ICH/FDA/EMA compliance standards.

Skills

Medical writing

Team leadership

Regulatory docs

Late-stage NDA/BLA/MAA

Job description

Position

Senior Director, Medical Writing

Location

Bay Area preferred

Reports To

SVP, Regulatory, Quality, and Pharmacovigilance

About the Company

Publicly traded, late-stage clinical biotech developing novel therapies for inflammatory diseases affecting the body, brain, and eye.

Role Summary

We're seeking a seasoned medical writer to build the function from the ground up - establishing infrastructure, standards, and processes, while hands-on authoring key clinical and regulatory documents in support of its growing late-stage pipeline.

Key Responsibilities

• Direct authoring of critical documents


• Build a scalable writing infrastructure, as well as budget/resourcing


• Oversee internal and external authors/vendors on writing deliverables


• Ensure documents meet ICH/FDA/EMA compliance standards

What You'll Need

• 10+ years of medical writing experience


• Smaller-company experience is a plus!


• Prior experience with quality, scientific/regulatory documents.


• Late-stage experience is wanted NDA/BLA/MAA


• Experience managing a team of direct reports