Medical Writer Specialist
hace 4 semanas
We are seeking a skilled Medical Writer to join our team at Aixial Group. As a Medical Writer, you will be responsible for creating and updating clinical documents, including protocols, study reports, and regulatory submissions.
Key Responsibilities:- Gather information from technical contacts, including medical writers, physicians, statisticians, and regulatory affairs 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.
- Evaluate and recommend standards and processes related to medical writing.
Aixial Group is a dynamic and collaborative international environment where your expertise directly impacts people's lives. If you are a highly skilled professional with a passion for the world of life sciences and clinical research, we encourage you to apply for this exciting opportunity.
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