Associate Professionals, Regulatory Systems & Data Management
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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. 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.
You will along with your colleagues be the source of knowledge of RA processes in relation to the use of Regulatory Systems such as Regulatory Information Management (RIM) and Electronic Document Management (EDMS). You will deliver best in class regulatory business support by challenging and advising the users of our Regulatory Systems across the global organization to continuously ensure an electronic platform, which provides consistent, transparent, accessible, real time regulatory data and electronic submission documents in a compliant and efficient way.
As an associate professional within Regulatory Systems and Data Management you are a key player when it comes to the use of our Regulatory Systems in the interface between RA headquarter, local RA, Sourcing Partner, Global Pharmacovigilance, Quality, IT and other internal stakeholders.
2 associate professionals within Regulatory Systems and Data Management for a period of 20 months in temporary positions with an interest in RA data, electronic documentation, systems and related processes. Perhaps you are newly educated or bring with you a couple of years of work experience, preferably from Regulatory Affairs (RA) and are acquainted with electronic systems used within RA. You are interested in optimizing and designing processes for the collection, entry, maintenance and tracking of RA data and documents for submission across global RA.
In addition, we are looking for a candidate who possess an analytic, systematic and structured mindset, with an interest in data, electronic documents and complex process, being highly solution oriented in your interactions with others and service minded with a good customer focus.
We are looking for a team player that values collaboration with colleagues, that are building networks and have interest in stakeholder management, you can plan and aligning task and ensuring a good overview in an intense work environment. It will be important to act with a global mindset and embrace cultural diversity as well as having a natural curiosity and proactive can-do-attitude.
You will be a part of a team with skilled and specialized regulatory systems and data management specialists, including close daily collaboration and contact with a central data entry team of 5 colleagues at our regulatory outsourcing partner. Your colleagues are highly skilled and dedicated within their area of expertise. They value a strong team spirit, working in an informal, supportive and humorous atmosphere.
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.
If you have questions, please do not hesitate to contact Jette Bruun Wessel, Head of Regulatory Data Management, at + 45 40339320.
. The deadline is
15th June 2021.
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.
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.
The job
You will along with your colleagues be the source of knowledge of RA processes in relation to the use of Regulatory Systems such as Regulatory Information Management (RIM) and Electronic Document Management (EDMS). You will deliver best in class regulatory business support by challenging and advising the users of our Regulatory Systems across the global organization to continuously ensure an electronic platform, which provides consistent, transparent, accessible, real time regulatory data and electronic submission documents in a compliant and efficient way.
As an associate professional within Regulatory Systems and Data Management you are a key player when it comes to the use of our Regulatory Systems in the interface between RA headquarter, local RA, Sourcing Partner, Global Pharmacovigilance, Quality, IT and other internal stakeholders.
Your tasks include:
- Provide support to users with inquiries and questions regarding system functionality or processes for our RIMS and EDMS
- Creation, execution and export of queries on request from users and support to or interpretation of results
- Support to the system change and maintenance processes with creation of test cases and testing of new processes and system validation according to GxP standards
- Developing and implementing RA processes for our systems - based on health authority requirements and regulatory intelligence knowledge
- Handling deviations and CAPA relating to regulatory data
- Participating in RA projects or other cross-functional projects
What we are looking for
2 associate professionals within Regulatory Systems and Data Management for a period of 20 months in temporary positions with an interest in RA data, electronic documentation, systems and related processes. Perhaps you are newly educated or bring with you a couple of years of work experience, preferably from Regulatory Affairs (RA) and are acquainted with electronic systems used within RA. You are interested in optimizing and designing processes for the collection, entry, maintenance and tracking of RA data and documents for submission across global RA.
Your qualifications
- relevant scientific degree
- preferably experience within the field of GxP IT systems
- preferably experience from working within regulatory affairs or related function
- process optimisation skills
- interest in engaging with and supporting users
- good communication skills both in written and oral English
- structured and analytical way of working
- good planning capabilities, delivering results on time, with a sense of urgency
- A team-player who values the synergies of working closely together with team-members
In addition, we are looking for a candidate who possess an analytic, systematic and structured mindset, with an interest in data, electronic documents and complex process, being highly solution oriented in your interactions with others and service minded with a good customer focus.
We are looking for a team player that values collaboration with colleagues, that are building networks and have interest in stakeholder management, you can plan and aligning task and ensuring a good overview in an intense work environment. It will be important to act with a global mindset and embrace cultural diversity as well as having a natural curiosity and proactive can-do-attitude.
Your new team
You will be a part of a team with skilled and specialized regulatory systems and data management specialists, including close daily collaboration and contact with a central data entry team of 5 colleagues at our regulatory outsourcing partner. Your colleagues are highly skilled and dedicated within their area of expertise. They value a strong team spirit, working in an informal, supportive and humorous atmosphere.
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 Jette Bruun Wessel, Head of Regulatory Data Management, at + 45 40339320.
. The deadline is
15th June 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.
Information og data
Denne ledige stilling har jobtypen "Data Manager", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 21.5.2021, 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.
- Data Manager
- Ballerup
- Tirsdag den 15. juni 2021
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