Senior Medical Writer - Remote, Regulatory Submissions Lead

ICON Clinical Research; México; Híbrido; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance offering

Retirement planning

Employee Assistance Programme (LifeWor

Life assurance

Childcare vouchers

Descripción de la vacante

ICON Strategic Solutions is seeking a Senior or Principal Medical Writer to lead high-quality regulatory and clinical document development that supports client submissions to regulatory authorities.

You will guide writing strategy, supervise team members, and ensure timelines and formats meet international regulatory standards across therapeutic areas. This role emphasizes independent leadership with minimal supervision and a focus on impactful submissions.

Formación

• Bachelor’s degree in science or health profession required.
• At least 5 years of pharma/biotech writing experience preferred; 3+ years in electronic documents and submissions.
• Experience writing key documents in major international regulatory submissions (e.g., Clinical study reports, IBs, Protocols).

Responsabilidades

• Lead medical writing document preparation and editing.
• Coordinate assignments to writers and review key regulatory documents.
• Lead writing strategy for regulatory submissions and responses.
• Ensure content consistency and regulatory compliance across programs.
• Represent Medical Writing on cross-functional teams and provide guidance.

Conocimientos

Medical writing leadership

Regulatory submissions

Editorial mastery

Communication skills

Educación

Bachelor's degree in science/health profession

Herramientas

Electronic submissions

Descripción del empleo

ICON Strategic Solutions is seeking a Senior or Principal Medical Writer to lead high-quality regulatory and clinical document development that supports client submissions to regulatory authorities.

You will guide writing strategy, supervise team members, and ensure timelines and formats meet international regulatory standards across therapeutic areas. This role emphasizes independent leadership with minimal supervision and a focus on impactful submissions.