Senior Medical Writer

PRA; Burgos; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Senior Medical Writer to support a Top-5 pharma company. In this role, you'll independently produce and ensure the submission readiness of various clinical and regulatory documents while collaborating closely with Principal Medical Writers. Your expertise in medical writing and strong analytical skills will be key in delivering high-quality documents across multiple therapeutic areas.

Formación

• 3-5 years of Medical Writing or relevant pharmaceutical experience.
• Ability to convert scientific data into clear, well-structured messages.
• Proficient in writing clinical/regulatory documents.

Responsabilidades

• Independently produce clinical and regulatory documents collaborating with Principal Medical Writers.
• Analyze and interpret data for document composition.
• Serve as the primary contact for document preparation and timelines.

Conocimientos

Strong writing skills

Scientific knowledge

Regulatory knowledge

Analytical skills

Descripción del empleo

Join the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence, as a Senior Medical Writer.

In this role, you will support a Top-5 pharma company, helping deliver best-in-class regulatory and submission documents. You will be fully embedded with our client while being employed by ICON.

Responsibilities :

• Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. These may include Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 in multiple therapeutic areas.
• Analyze and interpret data thoroughly to determine the best approach for document composition, applying lean writing strategies.
• Serve as the primary contact for the study team regarding preparation and timelines of assigned documents, including planning.
• Facilitate document reviews, ensuring they are submission-ready and approved, working closely with QC personnel and publishing specialists.

Minimum Requirements :

• 3-5 years of Medical Writing or relevant pharmaceutical experience with scientific and regulatory knowledge.
• Strong writing skills with the ability to convert scientific data into clear, well-structured messages.
• Proficient in independently writing various clinical / regulatory documents, mainly CSRs and Protocols, including leading creation, coordination, review facilitation, and ensuring submission readiness.

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