• 04 augustus 2022
  • vacaturenummer: 550134

Janssen Biologics BV, a member of Janssen, Family of Pharmaceutical Companies of Johnson & Johnson, is recruiting for an internship position in the Regulatory Submission Management and Operations Clinical Trial Management team in Leiden, The Netherlands.

€650 gross per month (based on 40 hours)

Leiden - the Netherlands

Learn and grow your potential

Develop your skills, knowledge and experience

Janssen Biologics a Johnson & Johnson company

The successful candidate will meet the following competencies: Following a Master course in Bioscience and has an interest in pharmaceutical development and organizational management. Fluent English in speaking and writing is required. The internship will be in line with the requirements as described by the university curriculum, the candidate must seek approval from the graduation committee prior applying to this role.

This position will be based in Leiden, The Netherlands. Regular meetings with a supervisor in the company will be arranged.

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.

Janssen develops treatments that improve the health and lifestyles of people worldwide.
Research and development areas encompass novel targets in neurologic disorders,
gastroenterology, oncology, infectious diseases, diabetes, hematology, metabolic disorders and immunologic disorders. Our ultimate goal is to help people live healthy lives.

The CTA submission management team within the Janssen Regulatory Submission
Management and Operations organization is responsible for driving the Regulatory Clinical Trial Applications (CTAs) for the 6 Janssen R&D Therapeutic Area’s: Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, Pulmonary Hypertension and the Infectious Disease & Vaccines TA. 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.

Are you interested in the internship? Please apply by the button!

Gideon van Staveren

Accountspecialist

Do you have questions? Please let me know by email.

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