Medical Writer (M / F)

Aixial Group; Burgos; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Aixial Group seeks a Medical Writer to contribute to clinical research. Responsibilities include writing clinical study reports, drafting regulatory documents, and collaborating with technical teams to ensure quality in document preparation. This dynamic role offers the opportunity to impact clinical research positively.

Formación

• Excellent writing and editing skills in English.
• Experience in clinical research or medical writing.

Responsabilidades

• Gather information from technical contacts and create clinical documents.
• Draft and co-write clinical study reports and oversee CRO activities.
• Contribute to operational plans and evaluate writing standards.

Conocimientos

Attention to detail

Medical writing

Communication

Educación

Degree in life sciences or related field

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.

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