Medical Writer at aixialgroup

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, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. 

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 in the UK or EU where we have the ability to hire.

PURPOSE AND MAIN RESPONSIBILITIES

Purpose

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

Responsibilities

·       Overall responsibility for co-ordinating and managing medical writing tasks, including timely delivery of high-quality documents in accordance with agreements made between Aixial and sponsor

·       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)

·       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

·       Perform project management of sponsor projects and internal Aixial projects

·       Training and mentoring of new medical writers

·       Adhere to company values

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

·       Provide timely feedback to Aixial management of work progress

·       Participate in planned training and read agreed material

·      Other medical writing tasks as needed

 For these responsibilities, the job holder is expected to perform the job under limited supervision. 

Required skills and qualities

·       Ability to structure and plan own work according to agreed timelines

·       Ability to manage own time

·       Excellent attention to detail combined with an understanding of the document’s overall purpose

·       Ability to work simultaneously on more than one project

·       Ability to establish and maintain effective working relationships with co-workers, managers and clients

·       Knowledge of GCP as well as relevant ICH guidelines

Job holder will typically have 5-10 years of relevant experience.

Technical skills

Good knowledge of Microsoft Office 365.

For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.