Clinical Medical Writer: Protocols, Reports & ICH Compliance

Jobtailor; Barcelona; Presencial; EUR 52.000 - 78.000; Jornada completa

Descripción de la vacante

Jobtailor in Barcelona, Spain, is seeking an experienced Medical Writer to compile and coordinate clinical documents, ensuring adherence to ICH E3 guidelines and regulatory standards.

You will review study protocols, clinical study reports, manuscripts, and investigator brochures, manage editorial reviews, and collaborate with clients and internal teams to deliver high-quality documentation on budgeted hours.

Formación

• Minimum experience as a medical writer with supervision.
• Ability to compile, write, edit, and coordinate medical writing deliverables.
• Ability to complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
• Knowledge of ICH E3 guidelines and regulatory standards.
• Ability to follow SOPs, templates, authorship requirements, and style guides.
• Ability to coordinate quality reviews and manage source documentation.

Responsabilidades

• Compile, write, edit, and coordinate medical writing deliverables.
• Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
• Apply regulatory standards and ICH E3 guidelines.
• Coordinate quality and editorial reviews and resolve client comments.
• Manage source documentation.
• Review statistical analysis plans and content for grammar and consistency.
• Build relationships with clients, department heads, and peers.
• Conduct online literature searches in compliance with copyright.

Conocimientos

Medical writing

Regulatory knowledge

Editorial coordination

Quality review

Budget management

Descripción del empleo

Jobtailor in Barcelona, Spain, is seeking an experienced Medical Writer to compile and coordinate clinical documents, ensuring adherence to ICH E3 guidelines and regulatory standards.

You will review study protocols, clinical study reports, manuscripts, and investigator brochures, manage editorial reviews, and collaborate with clients and internal teams to deliver high-quality documentation on budgeted hours.