Principal Strategic Medical Writer

Location: Chicago, Illinois, United States

Salary: $109,500–$208,500 per year

Company

hirify.global develops medicines and healthcare solutions in areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead and independently prepare clinical and regulatory documents supporting drug and device development.
• Coordinate cross-functional document reviews, approvals, quality control, and review meetings.
• Define writing processes, deliverables, content strategies, and project timelines.
• Contribute to project management strategies and lead activities supporting submission objectives.
• Drive tactical process improvements and resolve or escalate issues arising during document development.
• Work with R&D Quality Assurance to address inquiries and maintain inspection-ready documentation.

Requirements

• At least 5 years of experience in the biopharmaceutical, biotechnology, life sciences, or healthcare authority sector.
• Bachelor’s degree or higher; a scientific discipline is preferred.
• Extensive experience writing and editing clinical and regulatory documents under ICH, GCP, and other regulatory requirements.
• Advanced understanding of drug development, clinical research, study design, biostatistics, pharmacology, regulatory requirements, and medical terminology.
• Strong written and oral communication skills, analytical ability, organization, time management, and problem-solving skills.
• Ability to manage multiple projects and collaborate with cross-functional teams.

Nice to have

• Experience with CONSORT and PRISMA guidelines.
• Experience writing for EU and US medical devices.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for long-term incentive programs.
• Focus on innovation, integrity, and improving patient lives.