Principal Medical Writer

TL;DR

Principal Medical Writer (Clinical Research): Critically evaluate medical literature and write clinical development documents including protocols, investigator brochures, study reports, and regulatory modules with an accent on scientific rigor, statistical significance, and bias-free analysis. Focus on managing writing assignments under tight timelines, mentoring team members, and coordinating directly with clients.

Location: Remote within the UK

Company

Award-winning CRO supporting pharmaceutical, biotech, and medical device industries with scientific solutions for clinical trials and regulatory submissions.

What you will do

• Evaluate, analyze, and interpret medical literature to select resources for study design and documents.
• Write and edit clinical protocols, investigator brochures, study reports, consent forms, regulatory summaries, and publications.
• Manage timelines, workflow, and production of interpretive guides for projects.
• Interact independently with clients, using their templates and style guides.
• Mentor medical writers and project team members involved in writing processes.

Requirements

• Bachelor’s, Master’s or PhD in scientific, medical, or clinical discipline with at least 6 years of regulatory writing experience (Master’s or PhD preferred)
• Substantial experience as lead author on clinical study protocols.
• Experience leading teams while authoring regulatory documents under aggressive timelines.
• Exceptional writing, organizational, and multitasking skills.
• Expert in MS Word, Excel, PowerPoint, and related tools.
• Understanding of clinical data, federal regulations, GCP, and ICH guidelines.

Nice to have

• Experience in regulatory submissions to authorities.
• Project lead or team management experience.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Supportive, innovative, and collaborative work environment certified as Great Place to Work.
• Industry-leading employee retention and customer satisfaction.
• Global footprint across four continents fostering inclusive culture.