Regulatory Data Manager, Regulatory Data Management
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Ballerup
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 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 with data management and wants to impact strategic activities and improvement initiatives related to input and output of regulatory data from business tools and systems. The role also includes working with processes for data capture and data entry, analysis, and reporting, as well as intelligence on master data and data compliance requirements.
In this role you will be reporting to the Head of Regulatory Data Management. You will become a part of the Data Management team within Regulatory Business Operations & Compliance, with the remit and objective to develop and maintain expertise in industry requirements and developments relating to regulatory data management. Strengthening our use of data and information technology and secure Regulatory Information Management (RIM) as a key organizational capability. This includes fostering and nurturing strong stakeholder relationships with many functional areas across LEO Pharma, globally and locally.
Your deliverables will include:
-Annual Product Quality Review
-Aggregated Safety Reports/Period Safety Update Reports
-Pharmacovigilance System Master File
-Regulatory Serialization Data
-xEVMPD
In addition, we are looking for a candidate who possess an analytic, systematic, and structured mindset, with an interest in data 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 strong team player that values collaboration with colleagues, that are excellent in building networks and holds solid stakeholder management skills, as well as strong in planning and aligning tasks, 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 5 highly skilled and specialized regulatory data management specialists, including close daily collaboration and contact with a central data entry team of 6 colleagues at our regulatory outsourcing partner. 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
16-01-2022
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 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 with data management and wants to impact strategic activities and improvement initiatives related to input and output of regulatory data from business tools and systems. The role also includes working with processes for data capture and data entry, analysis, and reporting, as well as intelligence on master data and data compliance requirements.
The job
In this role you will be reporting to the Head of Regulatory Data Management. You will become a part of the Data Management team within Regulatory Business Operations & Compliance, with the remit and objective to develop and maintain expertise in industry requirements and developments relating to regulatory data management. Strengthening our use of data and information technology and secure Regulatory Information Management (RIM) as a key organizational capability. This includes fostering and nurturing strong stakeholder relationships with many functional areas across LEO Pharma, globally and locally.
Your deliverables will include:
- Defining and governing business processes for the use of regulatory data
- Perform training as relating to data entry and maintenance
- Participating in cross-functional projects as a subject matter expert
- Handling deviations and CAPA relating to regulatory data
- Extracting and analyzing data from regulatory and business systems, for the following processes (non-exhaustive list):
-Annual Product Quality Review
-Aggregated Safety Reports/Period Safety Update Reports
-Pharmacovigilance System Master File
-Regulatory Serialization Data
-xEVMPD
- Responsible for compliance with xEVMPD, IDMP and SPOR requirements and participation in
- external societies/networks around the same
- Participating as a subject matter expert in audits/inspections.
Your qualifications
- Master’s degree within life science, e.g. pharmaceutical or a related field
- Minimum 2 - 5 years of experience from the Pharmaceutical industry, with relevant experience from Regulatory Affairs globally or related functions (e.g. Safety, Quality Assurance, Product Supply or clinical with data management focus)
- Project management experience is a plus
- Knowledge about the regulatory framework and procedures globally is preferred. This include understanding of how RA contribute to the drug development process including life-cycle management and product release processes.
- Experience working with data management at a global level for pharmaceuticals and dealing with GxP-controlled data and reporting.
- Detailed knowledge of the IT landscape and systems used in regulatory data management, e.g. Regulatory Information Management Systems (RIMS) and Electronic Document Management Systems (EDMS)
- Strong oral/written communication skills in English
In addition, we are looking for a candidate who possess an analytic, systematic, and structured mindset, with an interest in data 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 strong team player that values collaboration with colleagues, that are excellent in building networks and holds solid stakeholder management skills, as well as strong in planning and aligning tasks, 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 5 highly skilled and specialized regulatory data management specialists, including close daily collaboration and contact with a central data entry team of 6 colleagues at our regulatory outsourcing partner. 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
16-01-2022
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 20.12.2021, 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
- Søndag den 16. januar 2022
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