Senior Medical Writer

Aixial Group; España; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading CRO is seeking an experienced Senior Medical Writer. The role involves coordinating and managing high-quality medical writing, including clinical study reports and regulatory submissions. Candidates must be familiar with ICH-GCP guidelines and enjoy a stimulating work environment that offers growth opportunities. The position is home-based or office-based/hybrid in select EU locations.

Formación

• Enthusiastic and talented Senior Medical Writer with ability to coordinate and manage tasks.
• Experience delivering high-quality medical writing output in accordance with sponsor agreements.
• Ability to work in alignment with ICH-GCP and participate in training sessions.

Responsabilidades

• Coordinate and manage medical writing tasks with timely delivery.
• Prepare clinical study reports and regulatory documents.
• Align work with company values and compliance requirements.

Conocimientos

Coordination of medical writing tasks

High-quality medical writing output

Experience with clinical study reports

Knowledge of ICH-GCP

Timely feedback provision

Descripción del empleo

Overview

Senior Medical Writer

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.

Responsibilities

• 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.
• Work in alignment with company values and in compliance with ICH-GCP, national and international regulations and the client’s quality system.
• 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.

Qualifications

• Enthusiastic and talented Senior Medical Writer with ability to coordinate and manage medical writing tasks.
• Experience delivering high-quality medical writing output in accordance with sponsor agreements.
• Experience with clinical study reports, Investigator’s Brochure updates, protocols, summaries and clinical overviews for regulatory submission.
• Ability to work in alignment with ICH-GCP, national and international regulations and the client’s quality system.
• Ability to provide timely feedback to management and participate in training sessions.
• Role may be home-based in the UK or EU, or office-based/hybrid in Denmark and Sweden.