Medical Writer Expert with Clinical Trials Experience

hace 3 semanas


Barcelona, Barcelona, España Cmed Group Ltd A tiempo completo

Company Overview

The Aixial Group is an international Contract Research Organization (CRO) part of the ALTEN Group, operating in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. As a CRO, it occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, with specialist expertise in oncology, cell & gene therapy, radiopharmaceuticals, and rare diseases.

About the Role

We are currently seeking an enthusiastic and talented Senior Medical Writer for home-based positions in the UK or EU where we have hiring capabilities. The ideal candidate will be responsible for performing medical writing tasks according to Aixial or sponsor SOPs, delivering high-quality documents within agreed timelines.

Main Responsibilities

  • Coordinate and manage medical writing tasks, ensuring timely delivery of documents.
  • Prepare documents such as clinical study reports, Investigator's Brochure updates, protocols, addendum reports, and summary documents for regulatory authorities, ethics committees, and investigators.
  • Develop skills within medical writing, maintaining knowledge of guidelines and requirements.
  • Write and review SOPs and procedures within Medical Writing, performing project management of sponsor projects and internal Aixial projects.
  • Train and mentor new medical writers, adhering to company values.

Requirements

To be successful in this role, you will require:

  • Able to structure and plan own work according to agreed timelines.
  • Excellent attention to detail combined with understanding of document purpose.
  • Ability to work simultaneously on multiple projects, establishing effective working relationships with coworkers, managers, and clients.
  • Knowledge of GCP and relevant ICH guidelines.
  • Typically 6-12 years of relevant experience.

Salary and Benefits

This role offers a competitive salary range $90,000 - $120,000 per annum, depending on experience, along with benefits that include opportunities for professional growth and development within a dynamic organization.


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