Principal Medical Writer (Clinical Research)

Location: Remote, must be based within the 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 documents, including protocols, investigator’s brochures, clinical study reports, informed consent forms, safety and efficacy summaries, regulatory submission documents, presentations, and publications.
• Manage writing assignments, timelines, workflows, and delivery against aggressive deadlines.
• Coordinate independently with clients and internal project teams across all aspects of assigned projects.
• Contribute to or manage the production of interpretive guides.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• Bachelor’s, Master’s, or PhD degree in a scientific, medical, clinical, or related discipline; a Master’s or PhD is preferred.
• At least 6 years of regulatory writing experience.
• Substantial clinical study protocol experience as a lead author.
• Experience leading and managing teams while authoring regulatory documents.
• Strong understanding of clinical data, exceptional writing skills, and excellent organization and multitasking abilities.
• Expert proficiency with MS Word, Excel, PowerPoint, client templates, and style guides.

Nice to have

• Experience with regulatory submissions, including clinical study reports submitted to regulatory authorities.
• Experience as a project lead or in managing a project team.
• Understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSPs/PIPs.

Culture & Benefits

• Full-time remote employment within the United Kingdom.
• Supportive, collaborative, and inclusive work environment.
• Work with pharmaceutical, biotech, and medical device clients on complex clinical research projects.
• Great Place to Work certified organization with a global presence across four continents.