Senior Medical Writer

PRA; Albacete; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Senior Medical Writer to support a Top-5 pharma company. The role involves independently producing clinical and regulatory documents and collaborating with Principal Medical Writers to ensure document submission readiness. Candidates should have 3-5 years of medical writing experience, strong writing abilities, and in-depth knowledge of scientific and regulatory standards.

Formación

• 3-5 years of Medical Writing or pharmaceutical experience.
• Strong writing skills and ability to convert scientific data into clear messages.
• Experience in writing clinical and regulatory documents.

Responsabilidades

• Produce clinical and regulatory documents, including Clinical Study Protocols and Reports.
• Serve as primary contact for study teams regarding document preparation.
• Facilitate document reviews to ensure submission readiness.

Conocimientos

Writing skills

Scientific knowledge

Regulatory knowledge

Data analysis

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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