Senior Professional, Regulatory Systems & Data Management

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. You will enter LEO Pharma and Global Regulatory Affairs at the most exciting period of time. Right now we are transforming our business unit and ways of working to meet the requirements of tomorrow and our corporate 2030 strategy.

Shaping and mobilizing the infrastructure with efficient processes, specialized data management and implementing modern technology/ IT-systems are the cornerstones in this highly strategic and business critical journey. Major challenges, big responsibility and on-going development are guaranteed in this position.

This role is ideal for a candidate who has a passion for working in the intersection between the Regulatory Affairs business area and IT. In this position you will be translating business requirements into system and technical solutions, taking ownership of an organizational transformation journey within the area of Regulatory Data Management. You will be driving the agenda of strengthening our use of data and information technology across not only Global Regulatory Affairs, but also across the wider LEO Pharma organization.

The job

In this role you will be reporting to the Head of Regulatory Systems & Data Management, forming part of the System Support & Training Team but primarily be allocated to the eRIMS replacement project.
Here you will be working on the project for replacing LEO Pharma’s Regulatory Information Management System going from Aris Global’s Register to Veeva’s Vault RIM - Registrations.

As part of the project activities you will contribute to the core project team as a subject matter expert, hereunder participating in the configuration track, designing the new application by translating the business needs to system requirements and specifications.

In this set-up you will be expected to drive sub-tracks in the project delivering to configuration of specific features. You will be owning the overall communication and alignment with Line of Business stakeholders, also external to GRA such as Global Safety, Global Supply Chain, Clinical Operations, Quality Assurance etc. The project team is working in accordance with the Agile SAFe methodology and consists of specialists from both the Global Regulatory Affairs function but also Global IT and Global QA.

Beside the primary allocation to the eRIMS replacement project, it is expected that you over time also contribute to other tasks and areas of responsibility within the remit of the System Support & Training team. Tasks and areas of responsibility for the broader team include:

• Defining and governing business processes for the use of IT systems and tools within GRA.
• Ensuring LoB compliance and adherence to GxP IT validation standards for GxP IT systems, including deviations handling and participation as subject matter expert in audits/inspections.
• Provide input and sparring with IT when generating IT documentation , authoring testcases and protocols for IT system functional/PQ testing
• Member and/or driver of IT LoB interface meetings
• End user support and responding to requests of various topics in relation to the use of GRA systems
• Defining and driving the training strategy, developing and maintaining training material as well as perform training for end users whenever needed.

Your new team

In this role you will join a team within the Regulatory Systems and Data Management department but at the same time also be allocated to the eRIMS Replacement Project Team.

The objective for the team is to administer systems and tools governed by Global Regulatory Affairs, providing business support and training to end-users across LEO Pharma.

The team holds the responsibility for the defined line of business IT processes, ensuring business continuity, compliance and adherence to GxP IT standards.

Your colleagues are highly skilled, dedicated and value a strong team spirit, working in an informal, supportive and humorous atmosphere. We welcome new colleagues by bringing your experience and ideas on board and provide training to ensure you excel in the role.

Your qualifications

Our ideal candidate has a master’s degree in Life Sciences, Computer Science or Engineering. You also have relevant experience from Regulatory Affairs or as a minimum the pharmaceutical industry with minimum 3-5 years of work experience with IT systems.

Experience with Regulatory Information Management (RIM) and/or Electronic Document Management (EDMS) systems and IT system validation (GxP) is a must. Hereunder specific experience with either Register or Veeva Vault RIM will be needed.

Ideally you have previous experience from participation in IT system implementation projects, working with development of User Requirement Specifications (URS), configuration and/or functional specifications, configurations, data migration strategies, execution plans, developing test protocols, performing PQ testing etc.

You generally possess in-depth knowledge of the IT landscape and systems/tools used within the Regulatory Affairs discipline including Microsoft Office 365 and you ideally bring experience working with Power BI, SharePoint Online or similar tools.

As a person you are service minded, customer focused with a robust mindset and a good sense of humor. You are a true team player and value close collaboration with your colleagues.
You approach tasks and responsibilities in a proactive manner and with an execution outlook. You are curious of nature, challenging the status quo, and are not afraid of taking part in discussions and decisions, driving efficient decision making processes.

You are able to apply an analytic, systematic and structured mindset, acquiring new knowledge, learn quickly and put this to use.

You plan and align tasks, ensuring a good overview in a work intense environment, being self-motivated and capable of driving tasks effectively through to completion.

Excellent proficiency in English will be an expectation together with good stakeholder management skills and the ability to navigate across cultural and professional diversities.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

If you have questions, please do not hesitate to contact Mia Thorne Hald, Head of Regulatory Systems & Data Management, at + 45 31 53 10 28.

We will review applications on an ongoing basis so please do not hesitate in applying via the link at our website and remember to attach application and CV. The deadline for application is 12th of September 2021.

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.