In this role, you will support our Regulatory team with general regulatory activities, maintaining regulatory intelligence, and assisting with submissions for (inter)national (multi-centre) clinical trials. Additionally, you will collaborate with the Medical and Safety team to support clinical safety activities for assigned projects.
Clinical Regulatory & Safety Officer
Are you an organized and detail-oriented professional with experience in regulatory affairs and clinical safety? Do you thrive in a dynamic environment where you can support crucial regulatory and medical activities? If so, we invite you to join our team as a Clinical Regulatory & Safety Officer.
• Maintain an intelligence database with (inter)national clinical legislation, requirements, and timelines.
• Assist in organizing general regulatory and medical & safety activities.
• Prepare trackers, systems, tools, and documentation for both teams.
• Manage filing and archiving of documents.
• Support tracking and planning activities to aid vendor management.
• Assist the Medical and Safety team with clinical safety reports and documents, such as SAE listings and MM reports.
• Collaborate with the Quality, Training, and Compliance department to ensure procedures, documentation, systems, and tracking tools are in place.
• Prepare submission packages for reviewing bodies in the Netherlands, Belgium, Ireland, and the United Kingdom.
• Organize meetings and ensure smooth communication within the teams.
• Conduct quality control activities to ensure high standards in the clinical trial submission process.
• A higher level of education, preferably in an administrative or biomedical field.
• Experience handling complex administration and digital data processing.
• Knowledge of EU Clinical Trial Regulation, ICH guidelines, and (inter)national submission regulations.
• Experience in (inter)national communication with reviewing bodies.
• Practical knowledge of medical terminology.
• Proficiency in Microsoft Office.
• Strong command of written and spoken English.
• A minimum of 3 years’ experience in a similar position.
• A collaborative and professional work environment.
• Opportunities for professional development and growth.
• A beautiful office location near Slot Zeist, easily accessible by public transport.
• Flexible working arrangements, with options to work from home, in the office, or a combination of both.
If you are interested in this role, please send your CV and motivation letter to vacancies@juliusclinical.com.
Questions?
For further inquiries, feel free to contact Ellen Hunink, HR Business Partner, at +31 621162980.
Our hiring process
Apply for this position
Send your application to vacancies@juliusclinical.com
Digital interview
You will receive an invitation for a digital meeting with the line manager and HR.
Interview at the office
You will receive an invitation for an interview at our office with your future colleagues.
Offer
If there is a match, you will receive an offer. Welcome aboard!