Medical Writer (M / F)

Aixial Group; Santa Cruz de Tenerife; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Aixial Group is seeking a Medical Writer to join their dynamic team in Santa Cruz de Tenerife. This role involves critical responsibilities in creating clinical study reports, ensuring compliance with regulatory standards, and directly impacting clinical research processes. Ideal candidates are passionate about life sciences and skilled in medical documentation.

Formación

• Highly skilled in clinical research and medical writing.
• Experience with regulatory documents and submission processes.
• Ability to gather information from diverse technical contacts.

Responsabilidades

• Gather information from medical writers and regulatory teams.
• Draft clinical documents for submissions and reports.
• Coordinate operational aspects related to document preparation.

Conocimientos

Clinical research

Medical writing

Regulatory submissions

Data Management

Statistical analysis

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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