Senior Medical Writer (Pharma)

TL;DR

Senior Medical Writer (Pharma): Critically evaluate medical literature and author clinical development documents including protocols, investigator’s brochures, study reports, and regulatory modules with an accent on scientific rigor, statistical significance, and bias-free analysis. Focus on managing aggressive timelines, leading teams in authoring submissions, and ensuring compliance with regulatory standards.

Location: Remote

Company

Innovative data-focused CRO supporting pharmaceutical, biotech, and medical device industries with scientific solutions for trial data and regulatory submissions, maintaining a global footprint across four continents.

What you will do

• Critically evaluate, analyze, and interpret medical literature to select primary resources for study design and scientific rigor.
• Write and edit clinical development documents including protocols, investigator’s brochures, study reports, consent forms, regulatory summaries, and publications.
• Manage timelines, workflow, and production of interpretive guides for writing assignments.
• Interact directly with clients, coordinate projects, and mentor junior writers and team members.
• Take ownership of assignments, consulting team members as needed for guidance.

Requirements

• At least 3-5 years of industry regulatory and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. in scientific, medical, or clinical discipline.
• 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 proficiency in MS Word, Excel, PowerPoint, and related tools.

Nice to have

• Experience in regulatory submissions to authorities.
• Strong understanding of federal regulations, GCP, and ICH guidelines.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Emphasis on enthusiasm, collaboration, and teamwork in a global, diverse environment.
• Focus on identifying top talent, continual training, and strengthening core skills.
• High customer satisfaction and proven scientific approach to client challenges.