Associate Director, Medical Writing (Biotechnology)

Location: Remote within the United States; preference for candidates within commuting distance of Thousand Oaks, California, or the San Francisco Bay Area. Periodic travel for team meetings and business needs is required.

Company

hirify.global is a biotechnology company developing clinical programs and advancing regulatory submissions.

What you will do

• Author, review, and manage clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, investigator brochures, briefing documents, and clinical sections of submissions.
• Lead document planning, development, review cycles, and comment resolution to deliver high-quality documents on schedule.
• Collaborate with Clinical Development, Clinical Operations, Statistics, Clinical Pharmacology, Regulatory Affairs, and other stakeholders to communicate complex scientific and clinical data.
• Develop and maintain medical writing templates, style guides, document standards, and best practices.
• Ensure compliance with FDA regulations, ICH guidelines, GCP, and other applicable requirements.
• Support INDs, CTAs, global regulatory submissions, regulatory responses, and process improvement initiatives.

Requirements

• Master’s degree or higher in life sciences, pharmacy, nursing, health sciences, or a related scientific discipline.
• At least 8 years of medical writing experience in biotechnology, pharmaceutical, or CRO organizations.
• Demonstrated expertise authoring clinical study protocols and clinical study reports.
• Experience supporting INDs, CTAs, or other regulatory submissions.
• Strong understanding of clinical drug development and regulatory requirements.
• Excellent scientific writing, communication, organizational, and project management skills, with the ability to manage competing priorities.

Nice to have

• Experience with clinical pharmacology content.

Culture & Benefits

• Remote work within the United States.
• Periodic travel for team meetings and other business needs.
• Flexible support for occasional extended hours during intensified activity and submission deadlines.
• Collaborative, detail-oriented work in a dynamic biotechnology environment.