Lead Submission Coordinator EU CTR

Johnson & Johnson Innovative Medicine

Warszawa

On-site

PLN 210,000 - 403,000

Full time

4 days ago

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Benefits offered by this job

Annual bonus

Vacation days

Comprehensive insurance

Job summary

Johnson & Johnson Innovative Medicine is seeking a Lead Submission Coordinator EU CTR to join our team in Prague, Czech Republic or Warsaw, Poland. This role coordinates operational submissions for EU clinical trials, collaborating with global and country teams to ensure timely CTIS submissions throughout the trial lifecycle.

The ideal candidate has 7+ years in R&D or regulatory affairs, strong project management, and English fluency.

Qualifications

Bachelor's degree required; advanced degree preferred.
Minimum of 7 years’ experience in R&D or regulatory affairs or a related function.
Fluency in English.
Excellent project management, presentation and communication skills.

Responsibilities

Lead the operational EU CTR submissions strategy, planning and delivery.
Set up and attend trial alignment, kick-off and planning meetings with stakeholders.
Create and maintain the submission plan from planning to initial and modifications approval.
Coordinate documentation and track submission progress with stakeholders.
Act as SME for designated areas and lead cross-functional projects.

Skills

Project management

Presentation skills

Communication

Stakeholder management

AI literacy

Education

Bachelor's degree

Advanced degree preferred

Tools

Microsoft Office

PM tools

Job description

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

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.

Principal Responsibilities

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.

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

Preferred Skills

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

The anticipated pay range for this position, in the primary posting location, is:

zł210,000.00 - zł402,500.00

The anticipated pay ranges for additional locations are:

Czech Republic - The anticipated base pay range for this position is 1,028,000 CZK - 1,967,650 CZK

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.