Medical Writer

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, India and Czech Republic.

Through Cmed (a part of the Aixial Group), the CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Medical Writer. This role can be home-based anywhere in the UK or EU (where we have the legal entity to hire). Some locations may require a partially remote hybrid in-office schedule.

**Core Accountabilities**:
The Medical Writer is responsible for performing medical writing tasks according to Cmed or sponsor SOPs as applicable, and in accordance with sponsor contracts.

**Principal Responsibilities**:
Overall responsibility for co-ordinating and managing medical writing tasks, including timely delivery of high-quality documents in accordance with agreements made between Cmed and sponsor

Prepare clinical study reports (pharma/biotech/devices), investigator’ s brochure (IB) updates,protocols, addendum reports and summary documents for submission to regulatory authorities, ethics committees and investigators

Prepare clinical evaluation reports for medical devices

Prepare publications (conference abstracts, posters, and manuscripts)

Keep updated in guidelines and requirements pertaining to medical writing

Maintain and develop skills within medical writing

Write and review SOPs and procedures within Medical Writing and Cmed

Perform project management of sponsor projects and internal Cmed projects

Training and mentoring of new medical writers

**Adhere to Cmed values**: Communication, Proactivity and Quality on time

Work in compliance with, ICH-GCP, national and international regulations and standards as well as Cmed’ quality system

Provide timely feedback to Cmed management of work progress

Participate in planned training and read agreed material

Additional

The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.