Senior Medical Writer

PRA; Marbella; 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 major pharmaceutical client. This role involves producing key regulatory documents across multiple therapeutic areas and requires strong writing and regulatory knowledge. If you're experienced in medical writing and ready to contribute to impactful projects, we want to hear from you.

Formación

• 3-5 years of Medical Writing or relevant pharmaceutical experience.
• Strong writing skills and proficiency in clinical/regulatory documents.
• Experience in leading document preparation and ensuring submission readiness.

Responsabilidades

• Produce clinical and regulatory documents, including CSRs and Protocols.
• Analyze data to determine effective document composition.
• Facilitate document reviews to ensure submission readiness.

Conocimientos

Medical Writing

Data Analysis

Regulatory Knowledge

Scientific Communication

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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