Senior Medical Writer

Aixial Group; Cartagena; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Aixial Group is seeking a Senior Medical Writer to manage and coordinate medical writing tasks associated with clinical trials. This role involves producing high-quality documentation for regulatory submissions while ensuring compliance with industry standards and supporting the company's goal of delivering innovative clinical trials efficiently. The position offers opportunities for professional growth in a stimulating work environment.

Servicios

Professional growth opportunities

Friendly and stimulating work environment

Formación

• Experience in clinical study reports and protocols.
• Familiarity with ICH-GCP and regulatory submission processes.
• Ability to deliver high-quality documents under deadlines.

Responsabilidades

• Coordinate and manage medical writing tasks for clinical documents.
• Ensure timely delivery of documents compliant with regulatory standards.
• Participate in training sessions and provide feedback on progress.

Conocimientos

Document Management

Regulatory Compliance

Clinical Writing

Educación

Degree in Life Sciences or related field

Descripción del empleo

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I – IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials.

We are currently looking for an enthusiastic and talented Senior Medical Writer for a client dedicated opportunity. This role is home-based in the UK or EU, or office-based / hybrid in Denmark and Sweden.

The successful candidate will be overall responsibility for coordinating and managing medical writing tasks, including timely delivery of high-quality documents in accordance with agreements made between Aixial and sponsor. Key medical writing tasks include clinical study reports, Investigator’s Brochure (IB) updates, protocols, as well as summary documents and clinical overviews for submission to regulatory authorities. The candidate will be expected to work in alignment with company values and in compliance with ICH-GCP, national and international regulations and the client’s quality system. They must provide timely feedback to management on work progress and actively participate in scheduled training sessions and required reading. Other medical writing tasks may be assigned as needed. Aixial offers a friendly and stimulating work environment, with ample opportunities for professional growth.

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