Are you a WO Master student with a background in bioscience, pharma or another related field? Do you have an interest in regulatory affairs within a pharmaceutical company? This may be the internship for you!
- 28 oktober 2021
- vacaturenummer: 495971
500 euro internship allowance
Johnson & Johnson
Are you a student that matches the following requirements:
- WO Master, with a study background in bioscience, pharma or other related field
- Fluent in English in speaking and writing
The internship will take at approximate 24 weeks and will include the following activities:
Introduction into regulatory CTA submission management activities. The intern will shadow an experienced submission manager and will get in- depth understanding of the regulatory guidance and regulations related to Clinical Trial Applications and the internal Janssen procedures on managing initial CTAs and submission activities to maintain the regulatory approval for different clinical trials.
In addition, during this time the intern will work on an individual project. Which will address a business challenge. The topic of this individual project will be determined together with the intern. Topics might include: how to implement new regulations (eg. the new EU clinical trial regulation, regulations around safety reporting in clinical trials, regulations related to clinical trials with Medical Devices) or other projects related to optimalization of business processes.
You will work at Johnson & Johnson, in the Regulatory Submission Management and Operations Clinical Trial Management team.
Janssen develops treatments that improve the health and lifestyles of people worldwide. R&D areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious diseases, diabetes, hematology, metabolic disorders and immunologic disorders. Their ultimate goal is to help people live healthy lives. They have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals.
The CTA submission management is responsible for driving the Regulatory Clinical Trial Applications (CTAs) for the 6 Janssen R&D Therapeutic Area’s.This is a centralized global team and is responsible for managing the preparation of Clinical Trial Applications and any CTA maintenance activities to the Regulatory agencies.
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