Medical Writer — Clinical & Regulatory, Madrid

Syneos Health, Inc.; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Syneos Health in Madrid, Spain is seeking a Medical Writer to join future roles on clinical study or regulatory project teams. You will write, edit, and coordinate content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects.

The role involves compiling documents such as study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures, while adhering to ICH E3 guidelines and client-approved templates.

Formación

• Experience compiling, writing, editing, and coordinating medical writing deliverables.
• Experience with clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
• Knowledge of regulatory standards, ICH E3 guidelines, templates, and authorship requirements.
• Ability to manage budget and deadlines and deliver on time and on budget.

Responsabilidades

• Compile, write, edit, and coordinate medical writing deliverables with moderate supervision.
• Prepare clinical study protocols, amendments, reports, narratives, and investigator brochures.
• Adhere to ICH E3 guidelines, SOPs, client templates, authorship requirements, and style guides.
• Coordinate quality and editorial reviews; ensure source documentation is managed; resolve client comments.
• Review statistical analysis plans and table/figure/listing specifications for content and grammar.
• Interact with clients and peers to produce writing deliverables.
• Perform online clinical literature searches and ensure copyright compliance.
• Identify and propose solutions to document issues, escalating as appropriate.
• Be aware of budget specifications and communicate status to leadership.
• Complete administrative tasks within deadlines; travel may be required (<25%).

Conocimientos

Medical writing

Editorial coordination

Client interaction

Regulatory compliance

Descripción del empleo

Syneos Health in Madrid, Spain is seeking a Medical Writer to join future roles on clinical study or regulatory project teams. You will write, edit, and coordinate content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects.

The role involves compiling documents such as study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures, while adhering to ICH E3 guidelines and client-approved templates.