Medical Writer (M / F)

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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