Regulatory System Support & Training Professional
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Ballerup
Are you ready for your next challenge as an IT-savvy professional working within Regulatory Affairs? Can you translate your unique capabilities, bridging and growing business relationships between Global Regulatory Affairs and IT, to support the entire organization? Then you are the person we are looking for!
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. 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 to excel in the role.
As a System Support and Training professional you will together with your colleagues administer systems and tools such as RIMS, EDMS, eCTD Viewer, E2E labelling tracking tool, all governed by Global Regulatory Affairs (GRA), providing business support and training to end-users across LEO Pharma. You will hold overall responsibility for the defined line of business IT processes, ensuring business continuity, compliance and adherence to GxP IT standards.
You will be heavily involved in end-user liaison and advocacy within and outside of GRA, as required for the use of our regulatory systems and tools. You will be responsible handling deviations relating to IT systems and tools within the scope of regulatory affairs.
You will ensure compliance and adherence to GxP IT system validation standards, driving tasks such as:
Providing input and sparring with IT when generating IT documentation Authoring testcases and protocols for IT system functional testing (Performance Qualification) Coordinating and performing testing, both informal and formal Leading or participating in IT/line of business interface meetings Participating and providing subject matter expertise in audits/inspections Supporting our helpdesk with 2nd level support in close collaboration with our superusers across the organization.
You will be responsible for developing and maintaining training material as well as training end-users in a global organization, which will include travelling days.
Experienced systems specialist
Our ideal candidate has a master’s degree in Life Sciences, Computer Science or Engineering. You have a relevant experience from regulatory affairs or as a minimum the pharmaceutical industry and 2-5 years of work experience with IT systems. Experience with Regulatory Information Management (RIM) and/or Electronic Document Management (EDMS) systems and IT system validation is a plus.
You possess good 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 actively participate in the activities of the team and department. You are curious of nature, challenge the status quo, and are not afraid of taking part in discussions and decisions.
You can 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.
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. 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 to excel in the role.
As a System Support and Training professional you will together with your colleagues administer systems and tools such as RIMS, EDMS, eCTD Viewer, E2E labelling tracking tool, all governed by Global Regulatory Affairs (GRA), providing business support and training to end-users across LEO Pharma. You will hold overall responsibility for the defined line of business IT processes, ensuring business continuity, compliance and adherence to GxP IT standards.
You will be heavily involved in end-user liaison and advocacy within and outside of GRA, as required for the use of our regulatory systems and tools. You will be responsible handling deviations relating to IT systems and tools within the scope of regulatory affairs.
You will ensure compliance and adherence to GxP IT system validation standards, driving tasks such as:
You will be responsible for developing and maintaining training material as well as training end-users in a global organization, which will include travelling days.
Experienced systems specialist
Our ideal candidate has a master’s degree in Life Sciences, Computer Science or Engineering. You have a relevant experience from regulatory affairs or as a minimum the pharmaceutical industry and 2-5 years of work experience with IT systems. Experience with Regulatory Information Management (RIM) and/or Electronic Document Management (EDMS) systems and IT system validation is a plus.
You possess good 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 actively participate in the activities of the team and department. You are curious of nature, challenge the status quo, and are not afraid of taking part in discussions and decisions.
You can 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 15.1.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
- Fredag den 31. januar 2020
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