Senior Medical Writer (Remote - UK)

Location: Remote, must be based within the UK; London, England, United Kingdom

Company

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

What you will do

• Critically evaluate and interpret medical literature to support study design, statistical significance, scientific rigor, and bias assessment.
• Write and edit clinical development and regulatory documents, including clinical protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and publications.
• Manage writing assignments, timelines, workflows, and interpretive guide production.
• Coordinate projects independently with clients and internal project teams.
• Take ownership of assignments and consult relevant subject-matter experts as needed.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• At least 3 years of pharmaceutical industry experience.
• At least 3–5 years of regulatory writing and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. degree in a scientific, medical, or clinical discipline.
• Substantial clinical study protocol experience as a lead author.
• Experience leading or managing project teams while authoring regulatory documents under aggressive timelines.
• Expert proficiency with MS Word, Excel, PowerPoint, client templates, and style guides, along with exceptional writing and organizational skills.

Nice to have

• Experience with regulatory submissions and clinical study reports presented to regulatory authorities.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSPs/PIPs.

Culture & Benefits

• Full-time employment with remote work from within the UK.
• Collaborative and inclusive working environment.
• Opportunity to work on complex clinical research and regulatory submission challenges.
• Supportive environment focused on professional development and mentoring.