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

Location: Remote — United Kingdom

Company

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

What you will do

• Lead regulatory and medical writing projects from initiation through completion.
• Write and review complex regulatory and medical documents while serving as a subject matter expert.
• Manage, mentor, and develop Medical Writing professionals, including Associate and I/II-level managers.
• Advise on regulatory updates, document standards, quality control tools, training, and writing processes.
• Manage client meetings, feedback, project risks, and resolution of client or delivery gaps.
• Use and train others on AI-assisted authoring technologies where appropriate.

Requirements

• College degree in a scientific, medical, clinical, or related discipline; a Master's or PhD is preferred.
• At least 6 years of experience in Regulatory and Medical Writing or a similar field.
• Direct experience managing, mentoring, and developing Medical Writing professionals.
• Experience with clinical trials, pharmaceutical development, CROs, and scientific or clinical terminology.
• Familiarity with 21 CFR Part 11, FDA, GCP, and current ISO 9001 and ISO 27001 standards.
• Strong problem-solving, organizational, communication, managerial, and MS Office skills.

Culture & Benefits

• Work remotely from the United Kingdom.
• Collaborative and inclusive work environment.
• Opportunities to lead important departmental initiatives and develop team members.
• Work within an award-winning clinical research organization with a global footprint.