.Job Description - EU Clinical Trial Submission Coordinator (2406185922W)EU Clinical Trial Submission Coordinator - 2406185922WDescriptionJohnson & Johnson is currently seeking a EU Clinical Trial Submission Coordinator to join our team located in Madrid, Leiden, Prague or Warsaw.About Johnson & JohnsonAt 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/.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.Careers.Jnj.Com .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.The EU CTR Clinical Trial Submission Coordinator (CTSC) is responsible for coordinating the operational and strategic submission aspects of EU clinical trial applications for the EEA region for internally managed trials. The CTSC 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
