GCO ED Internship

Johnson & Johnson Innovative Medicine; Neuss; Sur place; EUR 13 000 - 20 000; Plein temps

Résumé du poste

Johnson & Johnson in Germany is offering a Non-LDP Intern/Co-Op position within our Career Programs. You will support study planning activities, site start-up, execution, and close-out tasks across international trials.

The role emphasizes compliance with Credo, ICH-GCP, and local laws, with hands-on exposure to regulatory documentation and trial records while gaining practical trial-management experience.

Responsabilités

• Support trial documentation and preparation of study files pre-trial.
• Assist Trial Manager or Site Manager with EU-CTR submission preparation.
• Help obtain site-related trial documents and support IFDF processing.
• Assist in collecting, distributing, reviewing, and tracking regulatory documents and training docs.

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Career Programs

Job Sub Function

Non-LDP Intern/Co-Op

Job Category

Career Program

All Job Posting Locations

Neuss, North Rhine-Westphalia, Germany

Job Description

Study Planning Activities

• Trial documentation: Support the preparation of study files and of any other document required pre-trial.

Study Start Up Activities / Site start-up

• Support the Trial Manager (TM) or the Site Manager (SM) in EU-CTR Submission Preparation.
• Help the SM in obtaining site related trial documents.
• Support the TM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial.
• Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements, and training documentation.

Study Execution Activities

• Support TM/SM in ensuring that during the trial all relevant trial related documentation is provided to investigators and EC (if applicable) within the timelines.
• Support the TM/SM in maintaining the study files.

Study Close Out Activities

• Site closure: Provide administrative and logistic support to the TM/SM in activities related to study/site closure, as appropriate, and follow up of all items identified.

General Activities

• Base all actions on Credo. Protect the rights of others, protect privacy and company assets.
• Work in line with the HCC, company policies and procedures, including SOPs, having the ethical aspect in mind. Comply with ICH-GCP and all applicable local laws and regulations.
• Maintain communication with relevant parties within and outside the company.
• Actively follow trainings to ensure adequate qualification.
• Regularly update information in applicable systems and templates
• Contribute to maintain quality standards and timelines that are consistent with business needs
• Report every J&J product related complaint you receive to the company, under policies

Required Skills

Preferred Skills:

The anticipated pay range and benefits for this position is:

Da diese Position in einem Land veröffentlicht wird, das den EU‑Vergütungsanforderungen unterliegt, stellt das Talent Acquisition Team sowohl auf Anfrage als auch allen zu einem Interview eingeladenen Kandidaten Informationen zu den Gehaltsbereichen zur Verfügung.