Regulatory System Support & Training - Senior Professional

LEO Pharma A/S

Fuldtidsjob
Storkøbenhavn

Are you ready for your next challenge as an IT-expert working within Regulatory Affairs? Can you translate your unique capabilities, bridging and growing business relationships between Global Regulatory Affairs and IT? We are searching for a strong candidate with the right set of skills and mindset to take part in our exciting journey towards replacing our current Regulatory Information Management System (RIMS), bringing our regulatory information and data management to the next level.
At the forefront of dermatology
LEO Pharma has embarked on an ambitious growth journey to become a world leader in medical dermatology. This reflects our deep dedication to improve the quality of life for people living with skin diseases. Towards 2025, we are committing to helping more people by greatly accelerating our move into innovative treatments and new disease areas. Global Regulatory Affairs has set out to radically transform our business area including modernizing our IT landscape supporting and enabling the entire global organization towards our 2025 Goals.

Regulatory System Support & Training
You will join a team within the Regulatory Systems and Data Management department, which is part of Global Regulatory Business Support & Compliance. The objective for the team is to administer systems and tools governed by Global Regulatory Affairs (GRA), 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.

eRIMS replacement project
In this Senior Professional role, you will mainly be involved in our ongoing activities relating to replacing our current Regulatory Information Management System (Register, ArisGlobal) with Veeva’s Registrations on the Veeva RIM Vault. You will be part of the core project team as a subject matter expert, hereunder participating in the data track, significantly delivering input to and drive the line of business data migration strategy and data mapping. Examples of tasks within the project would entail the following:

  • Support the data track with business decisions in relation to the data migration strategy, migration waves, test strategies, and data quality strategies
  • Support the Data Architect and Vendor subject matter experts with detailed mapping rules, clarifying data extraction rules and describing how source data should be transformed to target data
  • Support Test Manager in building the test plan for the data migration as well as identifying, describing and creating PQ test cases, and executing PQ test cases before final system go-live
  • As a part of the project team be involved in the configuration of the new application by translating the business needs to system requirements and specifications. And be a part of the test and validation of the configured application.
  • Develop report specifications and the related test and validation

Experienced in implementing GxP IT systems
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 5-8 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. 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 bring experience working with Power BI, SharePoint Online or similar tools.

As a person you are service minded, customer-focused with a robust mind-set 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 you are curious of nature, challenging the status quo, and are not afraid of taking part in discussions and decisions.

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.

Contact and application deadline
For further information, please contact Head of Regulatory Systems & Data Management, Mia Thorne Hald on +45 31531028. Application deadline is 31th January 2020, however applicants may be called for interviews on an ongoing basis.

We look forward to receiving your application.

Apply now

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:
Permanent

Working hours:
Full-time

Working days:
Day

Application deadline:
31/01/2020

Location:
Ballerup, Greater Copenhagen, DK

Contacts:
Mia Thorne Hald
Mobile: +45 31531028

Company homepage:
http://www.leopharma.com

Office address:
LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit.

Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions.

LEO Pharma is headquartered in Denmark with a global team of 5,700 people, serving 80 million patients in 130 countries. In 2017, the company generated net sales of 1.4 billion euro.


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LEO Pharma A/S - hurtigt overblik


LEO Pharma A/S
LEO Pharma A/S
LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally.

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Industriparken 55
2750 Ballerup
Logo: LEO Pharma A/S
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