• Job title Clinical Trial Submission Coordinator
• Function R&D Operations
• Sub function Clinical Trial Project Management
• Category Senior Analyst, Clinical Trial Project Management (P6)
• Location Warsaw / Leiden / Prague / Beerse / Poland / Netherlands / Czechia / Belgium
• Date posted May 02 2025
• Requisition number R-011219
• Work pattern Hybrid Work

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Position Summary:
The Lead Submission Coordinator EU CTR is responsible for coordinating the operational and strategic submission aspects of EU clinical trial applications for the EEA region for internally managed trials. The Lead Submission Coordinator EU CTR collaborates with global and country teams to ensure all information and documentation for the submission to EMA’s Clinical Trial Information System (CTIS) are provided in a timely manner basis throughout the lifecycle of a clinical trial.

Principal Responsibilities:
1. Lead the operational EU CTR Submission strategy development, planning and delivery.
2. Set up and attend relevant trial alignment, kick-off and planning meetings with all relevant stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy.
3. Create and maintain the operational submission plan, in close collaboration with internal stakeholders Lead the EU CTR application process from operational planning to application (initial and modifications) approval.
4. Coordinate timely and accurate documentation, communicate submission progress and issue escalation.
5. Manage the internal systems to support EU CTR package planning and delivery.
6. Ensure required reports are generated and available for real time tracking of trial status.
7. Coordinate the RFI process in close collaboration with the internal partners.
8. Coordinate upload to CTIS.
9. Act as the primary contact person for EU CTR submissions in the Study Team.
10. Demonstrate deep knowledge of the EU CTR submissions process and CTIS requirements, provide input to trial teams.
11. Lead complex or challenging applications, including senior level reporting.
12. Act as SME for designated areas.
13. Lead cross functional projects (initiatives) or meetings in relation to operating model enhancements.

Principal Relationships:
This position reports to the Manager EU CTR. This position will partner closely with Regulatory Affairs, GCO Regional and Country teams, Global Development, and other organizations as required.

Education and Experience Requirements:
▪ Bachelor’s degree requires, advanced degree preferred.
▪ Minimum of 7 years’ experience working in Research & Development or Regulatory Affairs, or related function required.
▪ Excellent project management, presentation and communication skills required.
▪ Deep understanding of EU CTR and proven track record in either EU CTR submissions or multinational clinical trial submissions under the EU Clinical Trial Directive.
▪ Demonstrated experience being solutions and results oriented required.
▪ Ability to partner, influence and lead with a customer first mindset required.
▪ Ability to prioritize requests in alignment with the internal clients and propose effective alternatives when necessary required.
▪ Ability to onboard new staff as Submission Coordinator EU CTR.
▪ Demonstrated proficiency with the Microsoft Office Suite, and metric reporting and project management tools preferred.

Other:
▪ Language Requirement: Fluency in English
▪ Travel Percentage: 10% (Domestic & International)