Principal Medical Writer (Device)

Location: United States. Remote work is supported; new hires within a reasonably short commute of an office are encouraged to work on a hybrid basis as agreed with the manager.

Company

hirify.global provides consulting and operational expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Manage clinical program documents and complex regulatory submissions, including protocols, study reports, patient narratives, IBs, ICFs, PBRERs, INDs, NDAs, BLAs, MAAs, and eCTD documents.
• Independently author and edit clinical, safety, regulatory, device, diagnostic, and disclosure documents across clinical research phases and therapeutic areas.
• Coordinate internal resources, consultants, subject matter experts, and quality control reviews to deliver medical writing projects.
• Manage client expectations, lead project meetings, maintain timelines and deliverable trackers, and communicate scope or budget concerns.
• Review statistical analysis plans and table, figure, and listing shells for content, consistency, grammar, and format.
• Supervise, train, and mentor less experienced medical writers and contribute to departmental process-improvement initiatives.

Requirements

• At least 7 years of experience writing clinical and/or regulatory documents for drugs, biologics, medical devices, or diagnostics.
• Bachelor’s degree or higher, preferably in a medical or scientific discipline.
• Advanced knowledge of clinical research principles, clinical data interpretation, FDA regulations, regulatory guidelines, and submission requirements.
• Strong project management, communication, relationship-building, strategic collaboration, time-management, and attention-to-detail skills.
• English proficiency and familiarity with American Medical Association style.
• Expert proficiency in Microsoft Word, including tables, graphs, and figures, with the ability to work independently in a collaborative environment.

Culture & Benefits

• Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Employees are encouraged to contribute innovative, collaborative, and entrepreneurial ideas.
• Applications are personally reviewed by the recruitment team without AI screening tools.

Hiring process

• Applications are reviewed personally by a member of the recruitment team.
• Candidates receive an outcome on their application.