Principal Medical Writer (Medical/Regulatory)

TL;DR

Principal Medical Writer (Medical/Regulatory): Developing and managing high-quality clinical and regulatory documents for biotech and pharmaceutical clients with an accent on FDA compliance and complex submission documents. Focus on authoring protocols, IBs, and NDA/BLA submissions while leading cross-functional coordination and mentoring junior writers.

Location: United States. Supports remote work; hybrid arrangement encouraged for those living within a short commute of a company office.

Company

hirify.global provides expert consulting and end-to-end solutions to help biotech, medical device, and pharmaceutical organizations advance scientific breakthroughs.

What you will do

• Author and edit high-quality clinical, safety, and regulatory deliverables, including protocols, IBs, PBRER, IND, NDA, BLA, and MAA documents.
• Lead cross-functional coordination of resources to manage medical writing and QC deliverables.
• Supervise, train, and mentor junior medical writers.
• Collaborate with subject matter experts in clinical operations, data management, and biostatistics.
• Ensure all deliverables adhere to ICH E3/E6(R2), EU MDR/IVDR, and other regulatory standards.
• Manage client expectations directly and lead project kickoff and comment review meetings.

Requirements

• Must be based in the United States.
• Minimum of 7 years of experience writing clinical and/or regulatory documents for a CRO, pharma, or biotech company.
• Bachelor’s degree or higher, preferably in a medical or scientific discipline.
• Advanced knowledge of FDA regulations and regulatory submission processes.
• Expert proficiency in MS Word and familiarity with American Medical Association (AMA) style.
• Strong project management skills and high attention to detail.

Culture & Benefits

• Flexible work environment supporting both remote and hybrid models.
• Strong commitment to diversity, equity, and inclusion.
• Entrepreneurial and collaborative culture that encourages authenticity.
• Human-centric hiring process where all applications are personally reviewed without AI screening.