Regulatory Data Partner

7 days ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Are you passionate about working with data? Do you want to set directions and deliver results? Do you have the ability to handle complex tasks? If yes, we are seeking an experienced and highly motivated Regulatory Data Partner to join our team, who will be responsible for implementing and supporting our data in the Regulatory organisation, and support building and executing a comprehensive Data Governance strategy for the RQ&C area in Novo Nordisk.

Apply now for a life-changing career

The position

As a Regulatory Data Partner, you will have the responsibility on behalf of GRA and RA CMC to foster value creation by operationalizing data governance across the GRA and RA CMC organisation following the global framework.

Your main responsibilities will include:

  1. Create and maintain (master) data
  2. Analyse and resolve data challenges, with external standards (IDMP, XEVMDP, SPOR etc.)
  3. Provide process support and regulatory input to relevant projects, including IT projects
  4. Drive and support department-related activities as well as cross-functional tasks
  5. Keep up to date with current internal requirements and external guidelines and legislations within the area of responsibility
Qualifications

To be a competitive candidate, you should have:

  1. A bachelor's or master's degree in business administration, computer science, data science, information science or related field or equivalent work experience
  2. Minimum 3 years of work experience within relevant Regulatory Affairs or other key qualifiers as listed above
  3. Project Management and business management understanding
  4. Knowledge of industry standard regulatory data models (IDMP, XEVMDP, SPOR etc.) and knowledge of the overall RA business processes
  5. R&D Value Chain and pharma understanding

On a personal level, you naturally generate energy and direction among your colleagues, even during periods with tight deadlines. You have a high level of drive and result-orientation, you are curious and innovative by nature and like to be challenged. You thrive in agile and matrix setups and are comfortable interacting with stakeholders at different organisational levels. Finally, you are fluent in English, both written and spoken.

About the department

Digital Transformation is a department placed in RQ&C: RQ&C consists of the four functional areas: Regulatory Affairs (approvals by health authorities), R&D Quality (ensuring quality and compliance), Clinical Reporting (medical writing), and Digital Transformation (driving the Digital agenda). Furthermore, our department also supports the Global Safety area (patient safety and handling of adverse events).

Digital Transformation drives change within the RQ&C organisation to optimise and digitalise within and across the five areas. We collaborate with internal and external partners regarding projects within the fields of IT & Automation, Process Optimisation, and Data Analytics and Business Intelligence. In your work, you will get hands-on experience with best-practice project management methods and tools as well as optimisation of recurrent tasks.

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.

Contact

For further information, please contact Director of Data & Technology RQ&C Digital Transformation, Kristian Kiilerich at +45 3079 9629.

Deadline

30 March 2025

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 the communities we operate in. Together, we're life-changing.

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