Process Expert

1 month ago


Søborg, Denmark Novo Nordisk AS - VTx Full time

Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry?

We are looking for a Process Expert to join the implementation of IDMP in Vault RIM. Apply now for a life-changing career

The position
The Process Expert for Vault RIM and IDMP is key in ensuring a successful roll-out of IDMP in the system Vault RIM, triggered by increasing requirements from Health Authorities to exchange medicinal product information in a robust and consistent manner.

Your main responsibilities will be focused on:

Participating in the implementation of IDMP in Vault RIM, working with key stakeholders to ensure a successful rollout Performing data mapping and transformation activities to ensure accurate and complete migration of IDMP data to Vault RIM Continuously evaluate and improve IDMP data management processes and procedures and identify areas for optimization Understanding the Vault RIM platform to ensure IDMP implementation is aligned with existing business processes

Qualifications
To be a competitive candidate, you should have: A master’s degree in a relevant field, such as information science, pharmacy, or equivalent

At least, 3 years of experience in the pharmaceutical industry, preferably within Regulatory Affairs Experience in working with Vault RIM or a similar Registration Information Management system as well as knowledge on IDMP is an advantage Strong understanding of overall business processes, an analytical and quality mindset, and a flair for IT Fluency in English both written and spoken

On a personal level, you are curious to learn, well organised, a multitasker and a proactive problem solver. You enjoy working in a diverse and global team and you are good at communicating complex ideas clearly, effectively and with impact to enable business decisions. In addition, you thrive in an environment with changing circumstances and have a can-do attitude as well as a healthy sense of humour.

About the department
Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk.
 

In this role, you will have the unique opportunity to be part of a strategically crucial business transformation program across multiple processes and geographies and take active part in shaping the way Regulatory Affairs will work in the future.
 

You will join RA Submission Systems that plays a key role in supporting and enabling this transformation. The department consists of Vault RIM Process Experts and Business Administrators located in Denmark and India. In this position you will get the opportunity to join our team in Denmark. The atmosphere in the department is informal and our commitment to innovation also applies to the way we work. We embrace a flexible workplace, with a blend of in-office and remote work.



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