Regulatory Data Professional
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Søborg
Do you want to be at the forefront of developing the future labelling process and system? Do you want to drive innovation and digitalisation by pioneering and enabling novel technologies in pharma? Then join Future Labelling as our new data professional. Being part of Novo Nordisk Research & Development means working at one of the world’s largest and most successful pharmaceutical companies. Our R&D organisation is vital to the continued growth of Novo Nordisk, and we always welcome talented people who want to grow with us. About the department The Future Labelling department is part of Global Regulatory Affairs, which makes medicinal products available to patients all over the world by ensuring rapid regulatory approval in all markets. Global Regulatory Affairs is a fast-changing field with increasing external requirements and our business unit is making a meaningful difference to our business and patients. Future Labelling is responsible for new systems, processes and products related to the labelling text and packaging material process in Novo Nordisk, and the department collaborates very closely with other areas to achieve success. About the project You will be joining the NextGen Labelling project, an ambitious transformation project with global impact. We are building a collaborative platform to manage content and, through re-use and automation, optimise creation and maintenance of labelling texts and packaging materials for all products and devices globally. At present the project is running at full steam to realise the full potential of the current solution, while ramping up for the next big milestone, namely, to enable Structured Authoring. The benefits and impact to the organisation are significant as the project will lead to quality improvements (e.g., reduce risk of recalls), efficiency (e.g., less transactional work and spending time where it matters) and enable further digitalisation (e.g., e-labelling), and hence it is a meaningful project with a strong purpose and impact. The job In this job you will Define business requirements for the functionality in IT solutions supporting key regulatory business processes, such as the labelling component content management system (CCMS) Test the workflows built by the solution architects Document the technical specifications and new or changed business processes Give input to training material Analyse and resolve data challenges, with external standards in mind Troubleshoot process and system challenges to identify the right data solutions Analyse data & suggestions for business opportunities Give input about data changes to IT vendor Qualifications We expect that you bring: A curious, reflective mindset, comfortable navigating uncertainty and unknowns Knowledge of industry standard regulatory data models (IDMP, XEVMDP, SPOR etc.) Solid knowledge of DITA/XML Knowledge of the overall RA business processes Knowledge of RA stakeholder data landscape beyond RA Understanding of process impact of changes/additions to master data/value lists Life Cycle Management Regulatory Intelligence Regulatory therapeutic area and CMC knowledge Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. It is preferred that most of your working hours are done from Novo Nordisk office Søborg, Denmark, but it is not a hard requirement and remote work can also be a possibility. In that case you should expect travels to Denmark once a month. Contact For further information, please contact Kristian Kiilerich at +45 3079 9629. Deadline 05-04-2023, Please note that applications are screened on an ongoing basis, so you are encouraged to apply as soon as possible. Please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 3.4.2023, 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.
- Øvrige
- Søborg
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