Clinical Affairs Specialist
Clinical Affairs Specialist
Our client is searching for a Clinical Affairs Specialist to join their team. You will be working in a small (about 100), family owned company which has a range of products for wound and skin care. They have lots of new products in the pipeline as well as research cooperation agreements in the US and Europe.
If you want to work in a company that offers a flexible work system, great colleagues and a good salary package then you're in the right place.
This is full-time (40 hours per week) and permanent position. You will be located in the UK (Home-Office based), Belgium (Kontich) or Luxembourg.
What they offer:
- Excellent working conditions
- Independent project work & responsibilities within a professional team
- Great career opportunities in a fast growing company
- Learning and development opportunities
- Competitive pay + benefits
- Preparation of the technical clinical documentation in accordance with the new MDR Guidelines
- Support clinical trial protocols development and management of PMCF/clinical studies (Topical Medical devices as well as well as biological Pharmaceutical products and combination devices)
- Maintain quality and integrity of study data in accordance with company SOPs, applicable laws (MDR) and standard guidelines (ICH-GCP; ISO14155)
- Support review, preparation, coordination of CT submissions to ethics committees
- Support the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of clinical technical documentation activities
- Proactive collaboration with investigators/study team
- Provision of feedback to the clinical line manager regarding study progress
Your profile and qualifications:
- You will hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree
- Knowledge of the MDR Guidelines
- Knowledge of ISO 14155 Clinical investigation of medical devices for human subjects
- Experience with summary and analysis of clinical scientific literature
- Experience in clinical documentation in wound care or/and dermatology are an asset
- Experience with clinical statistical analysis is a plus
- English: fluent; Other languages such as e.g. German or Dutch would be an asset
If this job appeals to you please apply here or send your CV to me, Jared Holmes, on the NonStop Consulting website. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.
NonStop is one of the largest and fastest growing specialized life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxemburg, Switzerland, US, Romania and the Czech Republic. Please visit our website for a full list of the niche markets we cover.