Principal Medical Writer

Location: Remote - US

Salary: $152K–$190K per year

Company

hirify.global Therapeutics is a clinical-stage life-science and technology company developing novel medicines through an AI-driven discovery and development platform.

What you will do

• Plan, author, and deliver submission-ready protocols, investigator brochures, DSURs, CSRs, INDs, Health Authority responses, and briefing documents.
• Lead cross-departmental document development with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams.
• Represent Medical Writing on cross-functional study teams and ad hoc working groups.
• Support abstracts, posters, and presentations for scientific conferences.
• Establish and refine medical writing processes, templates, standards, workflows, and timelines.
• Evaluate and integrate AI-enabled tools to improve writing quality and efficiency.

Requirements

• Bachelor’s degree in life science or a health-related field.
• Minimum 10 years of relevant medical writing experience; an advanced degree such as a Master’s, PhD, or PharmD is preferred.
• Demonstrated experience with IND submissions and documents supporting clinical-stage programs.
• Excellent scientific writing, communication, organizational, and scientific judgment skills.
• Strong proficiency in Microsoft Office, particularly MS Word; familiarity with electronic document and reference management systems is preferred.
• Strong understanding of FDA and EMA regulations and ICH guidelines, with the ability to adopt new technologies including AI-enabled tools.

Culture & Benefits

• Fast-paced, evolving environment with cross-functional collaboration.
• Inclusive culture strengthened by diverse backgrounds, cultures, national origins, religions, sexual orientations, and life experiences.
• Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
• Uncapped vacation.
• Access to a state-of-the-art San Diego facility with an onsite gym and dining options.