Senior Medical Writer (Remote - Brazil)

Location: Remote within any location in Brazil; the posting lists Sao Paulo, Brazil.

Company

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

What you will do

• Critically evaluate medical literature and select scientifically rigorous, unbiased source materials for clinical study design.
• Write and edit clinical protocols, investigator’s brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and journal publications.
• Lead writing assignments, maintain timelines and workflows, and deliver high-quality documents under minimal supervision.
• Coordinate directly with clients and collaborate with project teams and internal departments.
• Contribute to or manage interpretive guides and provide proactive project ownership.
• Mentor medical writers and other project team members involved in regulatory writing.

Requirements

• At least 3 years of pharmaceutical industry experience and 3–5 years of regulatory 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 teams or project teams while authoring regulatory documents under aggressive timelines.
• Exceptional writing, organizational, multitasking, and client communication skills.
• Expert proficiency with MS Word, Excel, PowerPoint, client templates, and style guides.

Nice to have

• Experience with regulatory submissions and clinical study reports submitted 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 remote employment within Brazil.
• Collaborative and inclusive environment with a focus on professional growth.
• Great Place to Work certified organization with strong employee retention.
• Opportunity to support clinical research projects across a global CRO footprint.