Regulatory Compliance and Training Coordinator, GRA
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Hørsholm
Want to join a team of highly skilled regulatory information colleagues? Are you experienced in working with Regulatory Information Management Systems? And are you driven by having lots of interdisciplinary collaboration?
The position
You will be part of the Global Regulatory Affairs (GRA) department that counts approximately 60 people located at our headquarters in the DTU Science Park in Hørsholm.
As Regulatory Affairs Coordinator you will be given a range of responsibilities within the Compliance and Operations team in Global Regulatory Affairs - primarily as the GRA Training Coordinator and working within our Regulatory Information Management Systems (RIMS). The team consists of 7 great people including the manager of the team, whom you will work closely with.
Your field of responsibility covers
Your profile
Experience with learning management systems, preferably from the pharma industry is a plus but not a requirement. It will be an advantage as well that you have experience with Regulatory Information Management Systems, but not a requirement.
Furthermore, we expect of you to have
Become a part of ALK
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop yourself, solutions and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
Contact
Visit us at www.alk.net to learn more about our company. If you want to know more about the position, before submitting your application, please contact Manager, Jesper Kærgaard Kristensen on telephone +45 41 95 90 72.
We are looking forward to hearing from you!
The position
You will be part of the Global Regulatory Affairs (GRA) department that counts approximately 60 people located at our headquarters in the DTU Science Park in Hørsholm.
As Regulatory Affairs Coordinator you will be given a range of responsibilities within the Compliance and Operations team in Global Regulatory Affairs - primarily as the GRA Training Coordinator and working within our Regulatory Information Management Systems (RIMS). The team consists of 7 great people including the manager of the team, whom you will work closely with.
Your field of responsibility covers
- Acting as responsible for the Learning Management System (LearnIT) in GRA
- Coordination of the training process and the structure in LearnIT with input from management and instructors in Global Regulatory Affairs
- Training of GRA employees in LearnIT, QMS (Qualiy Management System), and our new Veeva RIM eDMS.
- Support to the authoring and reviewing process of QMS documents
- Potentially becoming also a local business administrator of Veeva Vault RIM, registrations and document management system, both regarding technical and business aspects
- Support to the local Veeva Vault RIM release process
Your profile
Experience with learning management systems, preferably from the pharma industry is a plus but not a requirement. It will be an advantage as well that you have experience with Regulatory Information Management Systems, but not a requirement.
Furthermore, we expect of you to have
- A strong analytical and structured approach to QMS documents and the authoring hereof
- The ability to work within a team, and provide the best possible support to our stakeholders
- Fluency in Danish and English
- A good sense of humor and the wish to be part of a successful and hardworking team
Become a part of ALK
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop yourself, solutions and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
Contact
Visit us at www.alk.net to learn more about our company. If you want to know more about the position, before submitting your application, please contact Manager, Jesper Kærgaard Kristensen on telephone +45 41 95 90 72.
We are looking forward to hearing from you!
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 23.2.2023, 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.
- Forretningsudvikler
- Hørsholm
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