Senior Manager, Regulatory and Medical Writing (Remote - US)

Location: Remote in the United States, across multiple states

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission challenges.

What you will do

• Lead regulatory and medical writing projects from initiation through completion.
• Apply medical writing styles and standards across complex document types and serve as a subject matter expert.
• Mentor, supervise, and develop medical writing professionals and managers.
• Monitor regulatory updates and advise on their impact on deliverables and organizational practices.
• Use and train others on medical writing, quality control, and AI-assisted authoring technologies.
• Manage client meetings, feedback, project risks, gaps, and issue resolution.

Requirements

• College degree in a scientific, medical, clinical, or related discipline, or equivalent experience.
• At least 6 years of experience in regulatory and medical writing or a similar field.
• Direct experience managing, mentoring, and developing medical writing professionals.
• Strong managerial, communication, problem-solving, organizational, and client-management skills.
• Familiarity with FDA, GCP, 21 CFR Part 11, and current ISO 9001 and ISO 27001 standards.
• Proficiency with Microsoft Office; clinical trial and pharmaceutical development experience is preferred.

Culture & Benefits

• Collaborative and inclusive work environment.
• Supportive team focused on innovation and scientific quality.
• Opportunity to contribute to clinical research and regulatory submission programs.
• Full-time employment with a globally operating clinical research organization.