Senior Medical Writer — Regulatory Strategy Lead

Icon; México; On-site; MXN 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Life assurance

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions is seeking a Senior/Principal Medical Writer to lead the development of regulatory and clinical documents. You will guide writing, coordinate writers, perform substantive editing, and support regulatory submissions with an expert understanding of global guidelines.

Preferred candidates have 5+ years pharma/biotech writing experience, strong communication skills, and experience with major international submissions.

Qualifications

• Bachelor's degree in science or health profession.
• At least 5 years of experience writing for pharma or biotechnology.
• 3+ years of electronic documents and submissions experience.
• Experience with major international regulatory submissions (Clinical study reports, IBs, Protocols) preferred.

Responsibilities

• Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing.
• Lead writing strategy and provide timelines and resource planning for regulatory submissions.
• Prepare key regulatory response documents and support major regulatory submissions (INDs, marketing applications).
• Represent Medical Writing on cross-functional teams and act as a Medical Writing contact for regulatory strategy.
• Lead on important regulatory components and ensure content consistency across programs.

Job description

ICON Strategic Solutions is seeking a Senior/Principal Medical Writer to lead the development of regulatory and clinical documents. You will guide writing, coordinate writers, perform substantive editing, and support regulatory submissions with an expert understanding of global guidelines.

Preferred candidates have 5+ years pharma/biotech writing experience, strong communication skills, and experience with major international submissions.