Medical Writer (M / F)

Aixial Group; Torrejón de Ardoz; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Aixial Group is seeking a Medical Writer who will contribute to the future of clinical research. The successful candidate will gather information, draft clinical documents, and oversee operational aspects of CRO activities. Join a dynamic team that directly impacts people's lives in the life sciences sector.

Responsabilidades

• Gather information from technical contacts including medical writers and physicians.
• Create and update abbreviated protocols, amended protocols, and lay protocol synopsis.
• Draft various clinical documents required for regulatory submissions.

Descripción del empleo

You are a highly skilled professional with a passion for the world of life sciences and clinical research. You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people's lives.

Come and join Aixial Group to contribute to shaping the future of clinical research!

We are currently seeking a Medical Writer (M / F) whose main responsibilities will include (non-exhaustive list) :

Key responsibilities :

• Gather information from technical contacts (medical writers, physicians, statisticians, regulatory affairs, and pharmacovigilance team members).
• Create and update abbreviated protocols, amended protocols, and lay protocol synopsis.
• Co-write and write clinical study reports for phase 1 to 4 studies.
• Draft various clinical documents required for regulatory submissions and study management.
• Oversee the operational aspects of Clinical Research Organization (CRO) activities related to document preparation.
• Serve as the medical writer in charge of P70 / PRCI and EU CTR coordination tasks.
• Contribute to the creation of Q&A documents, briefing books, and benefit-risk assessments.
• Contribute to the production of operational plans (Data Management Plan, Statistical Analysis Plan, Statistical Validation Plan).
• Evaluate and recommend standards and processes related to medical writing.

J-18808-Ljbffr