Senior Medical Writer (Clinical Regulatory Writing)

Location: Remote within Argentina; Buenos Aires, Argentina.

Company

hirify.global is an award-winning, 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 and interpret medical literature to support study design and regulatory documentation.
• Write and edit clinical protocols, investigator’s brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, regulatory submission documents, presentations, and publications.
• Manage writing assignments, timelines, workflows, and deliverables under minimal supervision.
• Coordinate directly with clients and collaborate with project teams and other departments.
• Contribute to or manage interpretive guides and provide scientific input on projects.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

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

Nice to have

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

Culture & Benefits

• Full-time employee position with remote work from within Argentina.
• Supportive, collaborative, and inclusive work environment.
• Great Place to Work certified organization with a strong employee retention record.
• Opportunity to work with global pharmaceutical, biotech, and medical device clients.