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, 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. This role is 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 most tasks independently. 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 6-12 years of relevant experience. Technical skills Good knowledge of Microsoft Office 365. Languages The job holder will need to be fluent in spoken and written English.
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