Junior Clinical Quality Associate
vor 4 Wochen
Location: Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a
**Junior Clinical Quality Associate**
In this role you will act as a primary point of contact for our clinical operations teams for all quality related issues. Implementing clinical quality assurance oversight and integrating clinical operations into Novocure’s quality system. You furthermore provide consultancy and training to stakeholders and work on the continuos improvement of our quality system, contributing strongly to Novocure’s future success.
**Your responsibilities**:
- You act as a clinical quality assurance key contact to clinical operations and support clinical studies and internal stakeholders.
- You support inspection preparation activities and ensure their timely and consistent reporting and communication.
- You provide GCP advice and support Clinical Development, Clinical Operations, Clinical Safety and Clinical Supply Chain,
- You assist with the development of quality assurance procedures and review of clinical development and clinical operations procedures.
- You assist and support in the development of Novocure’s Quality Management System, focusing on incorporating Clinical Operations Processes into the QMS
- You manage quality compliance issues, CAPAs, complaints, and their consistent communication.
**Your profile**:
- You bring a Scientific Degree in a Medical, Pharmaceutical, Scientific or any other related field.
- You have initial experience of medical device or drug development with experience in clinical development, quality management and inspection readiness.
- You have experience with regulatory inspections and knowledge of regulation for Medical Devices such as EN ISO 14155, ICH-GCP
- You bring excellent written and verbal communication skill in English. German language skills are a plus.
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