Senior Medical Writer: Lead Clinical Study Docs

ThermoFisher Scientific; Chile; A distancia; CLP 20.088.000 - 35.712.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Professional development opportunities

Global team environment

Descripción de la vacante

Thermo Fisher Scientific seeks a Medical Writer to deliver high-quality scientific writing from planning through final drafts for internal and external clients.

Responsibilities include authoring routine documents like study reports and protocols, supporting complex documents (IBs/INDs/MAAs), and ensuring compliance with quality processes while aiding in timelines and budgets. Strong communication and regulatory knowledge are essential.

Formación

• Bachelor's degree in a scientific discipline or equivalent
• 2+ years of related experience in medical writing or pharmaceutical/ CRO industry preferred
• Experience with regulatory documentation and drug development process advantageous

Responsabilidades

• Serve as primary author for routine documents such as clinical study reports and study protocols
• Assist with more complex documents including IBs, INDs, and MAAs
• Ensure compliance with quality processes and determine best practices for deliverables
• Assist in program management activities, timelines, budgets and forecasts
• Represent the department at project meetings and reviews

Conocimientos

Medical writing

Data interpretation

Documentation management

Regulatory knowledge

Team collaboration

Communication skills

Attention to detail

Planning and scheduling

Educación

Bachelor's degree in a scientific discipline

Herramientas

Excel

Outlook

Descripción del empleo

Thermo Fisher Scientific seeks a Medical Writer to deliver high-quality scientific writing from planning through final drafts for internal and external clients.

Responsibilities include authoring routine documents like study reports and protocols, supporting complex documents (IBs/INDs/MAAs), and ensuring compliance with quality processes while aiding in timelines and budgets. Strong communication and regulatory knowledge are essential.