Lead Submission Coordinator EU CTR

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 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: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Prague, Czechia, Warsaw, Masovian, Poland Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson is currently seeking a Lead Submission Coordinator EU CTR to join our team located in Prague, Czech Republic or Warsaw, Poland. 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.

Lead the operational EU CTR Submission strategy development, planning and delivery. 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. 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. Coordinate timely and accurate documentation, communicate submission progress and issue escalation. Manage the internal systems to support EU CTR package planning and delivery. Ensure required reports are generated and available for real time tracking of trial status. Coordinate the RFI process in close collaboration with the internal partners. Coordinate upload to CTIS. Act as the primary contact person for EU CTR submissions in the Study Team. Demonstrate deep knowledge of the EU CTR submissions process and CTIS requirements, provide input to trial teams. Lead complex or challenging applications, including senior level reporting. Act as SME for designated areas. Lead cross functional projects (initiatives) or meetings in relation to operating model enhancements.

Requirements: Bachelor’s degree requires, advanced degree preferred. Minimum of 7 years’ experience working in Research & Development or Regulatory Affairs, or related function required. Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes. Excellent project management, presentation and communication skills required. Deep understanding of EU CTR and proven track record in either EU CTR submissions or multinational