Senior Medical Writer

buscojobs España; Cádiz; Presencial; EUR 40.000 - 60.000; 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 producing regulatory documents, analyzing data, and ensuring submission readiness. Ideal candidates have 3-5 years of experience in medical writing and strong communication skills.

Formación

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

Responsabilidades

• Produce clinical and regulatory documents in collaboration with Principal Medical Writers.
• Analyze data to determine document composition strategies.
• Serve as primary contact for study team regarding document preparation.

Conocimientos

Medical Writing

Scientific Knowledge

Regulatory Knowledge

Data Analysis

Strong Writing 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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