Senior Medical Writer — Regulatory Submissions Lead

ICON; Ciudad de México; On-site; MXN 1,057,082 - 1,585,623; Full time

Benefits offered by this job

Competitive salary

Annual leave entitlements

Health insurance options

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Gym memberships

Job summary

ICON in Mexico City is seeking a Principal Medical Writer to lead the creation of high-quality regulatory documents. This role involves guiding document preparation, ensuring regulatory compliance, and managing key submissions.

The ideal candidate will have a Bachelor's degree and extensive experience in medical writing for pharmaceuticals. Responsibilities include overseeing document timelines and providing leadership on cross-functional teams.

ICON offers competitive salaries, health insurance options, and various employee benefits.

Qualifications

• 5+ years of experience writing for pharma or biotechnology.
• 3+ years of electronic documents and submissions.
• Experience managing writing activities for major regulatory submissions.

Responsibilities

• Lead the development of regulatory and clinical documents.
• Guide medical writing document preparation and review.
• Manage deliverables for submission to regulatory agencies.

Skills

Medical writing for pharma

Regulatory document preparation

Project leadership

Interpersonal skills

Education

Bachelor’s degree in science or health profession

Job description

ICON in Mexico City is seeking a Principal Medical Writer to lead the creation of high-quality regulatory documents. This role involves guiding document preparation, ensuring regulatory compliance, and managing key submissions.

The ideal candidate will have a Bachelor's degree and extensive experience in medical writing for pharmaceuticals. Responsibilities include overseeing document timelines and providing leadership on cross-functional teams.

ICON offers competitive salaries, health insurance options, and various employee benefits.