Medical Writer Specialist

hace 5 días


Barcelona, Barcelona, España Cmed Group Ltd A tiempo completo

The Aixial Group is a leading International Contract Research Organization (CRO) with offices in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. Our mission is to conduct clinical trials better than anyone else, helping patients and saving lives. We have earned a strong reputation for delivering complex, demanding, and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals, and rare diseases.

We are currently looking for an enthusiastic and talented Senior Medical Writer to join our team. This role is home-based in the UK or EU, where we have the ability to hire.

Job Description

To perform medical writing tasks according to Aixial or sponsor SOPs as applicable, and in accordance with sponsor contracts. 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.

Main Responsibilities
  • Prepare documents such as clinical study reports, Investigator's Brochure (IB) updates, protocols, addendum reports, and summary documents for submission to regulatory authorities, ethics committees, and investigators.
  • Prepare clinical investigation/evaluation reports for medical devices.
  • Prepare scientific publications (conference abstracts, posters, and manuscripts).
Key Requirements
  • Ability to structure and plan own work according to agreed timelines.
  • Excellent attention to detail combined with an understanding of the document's overall purpose.
  • Ability to work simultaneously on more than one project.
  • Knowledge of GCP as well as relevant ICH guidelines.
Benefits

As a Senior Medical Writer at Aixial, you can expect a competitive salary of £60,000 - £80,000 per annum, depending on experience. Additionally, you will have opportunities for professional growth and development, as well as a collaborative and dynamic work environment.


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