Digital Solution Professional - Regulatory Affairs (RIM)

Application deadline: 11/11/2024 
Location: Gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 2646 

Senior Digital Solution Specialist 

Are you a seasoned digital solutions expert with a passion for administering and improving systems in a pharmaceutical setting? Do you thrive in a dynamic environment where your expertise can drive compliance and innovation? At LEO Pharma, we are dedicated to helping people achieve healthy skin through groundbreaking treatments. We invite you to join our Digital Solution Management team in Gdańsk, Poland, where you will play a crucial role in supporting our R&D and Global Safety systems. 

Shape the LEO Pharma of tomorrow   

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! 

In Digital Solution Management we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals. 

Your Role 

As a Senior Digital Solutions Specialist, you will lead strategic activities and improvement initiatives, administer systems and tools governed by Global Regulatory with a specific focus on Global Safety systems and provide business support to end users across LEO Pharma. You will be a point of contact regarding RIM Vault business admin, functional sup-port and general release activities Your key responsibilities will include: 

• Proactively liaise with end users on complex matters, provide advanced functional support, and act as the point of contact for outsourcing partners  

• Define and govern business processes for IT systems and tools within Global Regulatory, and develop proposals for improvement. 

• Manage RIM backlog, Vault releases in collaboration with the LoB functions in Global Regulatory Affairs area, HCL, Veeva and IT. 

• Ensure compliance with GxP IT validation standards, handle deviations, and drive the timely completion of CAPAs. 

• Defining and driving the training strategy, developing and maintaining training material and perform training to end users 

• Act as a subject matter expert in cross-functional projects and take on project leadership roles when required. 

Your Qualifications 

To excel in this role, you will need: 

• Bachelor or higher degree in computer science, engineering, natural science, business, or similar. 

• Solid experience working within a pharmaceutical and/or regulated environment, with in-depth experience dealing with GxP and IT system validation. 

• A deep understanding of IT system administration, user access, and end-user training principles. 

• Excellent stakeholder management skills and the ability to navigate across cultural and professional diversities. 

• Proficiency in verbal and written English, good communication skills, and the ability to multitask and think ahead. 

Your New Team 

Welcome to the Digital Solution Management team at LEO Pharma! You will join a dedicated group of professionals committed to ensuring our digital solutions are robust, compliant, and effective. Reporting to the Senior Manager, you will collaborate closely with various internal departments and external partners. Our team values open communication, collaboration, and a shared commitment to excellence, continually pushing the boundaries to deliver innovative solutions. 

Contact and Application 

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application! 

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities. 

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.  

Beyond the skin  

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.   

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.  

For certain positions, LEO Pharma might complete a background check conducted by a third party.  

Join us on our journey Beyond the Skin. Apply today!