Clinical Compliance Coordinator with focus on quality and process optimisation

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Søborg

  • Quality
  • Søborg

R&D Quality, Global Development, Denmark

Your opportunity
Do you wish to take part in the team working with our Quality Management System (QMS) ensuring high quality, optimisation and standardisation of our processes?

If so, you may be our new Clinical Compliance Coordinator in R&D Quality, Global Development.

In Global Development, we take responsibility for new products based on proteins and peptides from early development phases to product introduction. We are responsible for managing clinical drug development worldwide, securing that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.

About the department
R&D Quality is divided into three departments. The open position as Clinical Compliance Coordinator, is within the Global Clinical & Research QMS department. In this department, we are responsible for maintaining our global QMS, and we have continued focus on optimising our processes while at the same time maintaining a high level of quality. We drive the update of clinical trial standard operation procedures (SOPs), lead the ISOtrain set-up, QualityDocs usage and provide GCP support in Global Development.

The position
Together with 14 colleagues, you will be responsible for ensuring that Novo Nordisk maintains the global clinical QMS in compliance with GCP and other relevant external and internal requirements. As a QualityDocs editor, you will be part of the team maintaining the clinical trial SOPs in accordance with relevant schedules and requirements. You will be working with Veeva Vault QualityDocs, where you as editor are responsible for ensuring document maintenance and compliance with the system.

You will be working closely with your colleagues within the department and with stakeholders in other areas of Novo Nordisk. It is essential that you are an excellent team player, that you are motivated by taking the supportive role within the team and that you like building networks with relevant stakeholders within headquarters and the affiliates.

Qualifications

You have a bachelor’s degree in business language (English) or equivalent or English as native language, and experience from a similar support function as well as experience within the clinical area in the pharmaceutical industry. You are an experienced user of Office 365 and motivated to master new IT systems.

The ideal candidate will have a strong quality mindset and a high degree of initiative and independence. You are well structured with an eye for detail without loosing the overview. To be successful in this job you need to be both service-minded, and a positive team player.

Contact

For further information, please reach out to Susanne Witzke (SWIT), +45 3079 2273.

Deadline

18 June 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


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 3.6.2020, 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
  • Torsdag den 18. juni 2020

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