Senior Medical Writer (Remote - Mexico)

Location: Remote within any location in Mexico; the posting lists Mexico City, Mexico.

Company

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

What you will do

• Critically evaluate and interpret medical literature to support study design and scientifically rigorous regulatory documents.
• Write and edit clinical protocols, investigator brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and publications.
• Manage writing timelines, workflows, assignments, and project deliverables.
• Coordinate independently with clients and cross-functional project teams.
• Contribute to or manage interpretive guides and provide project writing expertise.
• Mentor medical writers and other contributors involved in the writing process.

Requirements

• At least 3 years of pharmaceutical industry experience, including 3–5 years of regulatory and clinical medical writing.
• Bachelor’s, master’s, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial clinical study protocol experience as a lead author.
• Experience leading teams or project groups while authoring regulatory documents under aggressive timelines.
• Strong understanding of clinical data, exceptional writing skills, and excellent organizational and multitasking abilities.
• Expert proficiency with Microsoft Word, Excel, PowerPoint, client templates, and style guides.

Nice to have

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

Culture & Benefits

• Full-time employee position with remote work from anywhere in Mexico.
• Collaborative and inclusive environment within a global clinical research organization.
• Work supporting pharmaceutical, biotech, and medical device studies.
• Opportunity to contribute to complex regulatory submissions and mentor other writers.

Hiring process

• Applications are reviewed after submission.
• If there is no contact within 14 days, the application should be considered unsuccessful.