GCP Advisor Specialist

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Søborg

  • Quality
  • Søborg

GCP Advisor Specialist for R&D Quality

Your opportunity

Do you wish to use your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment then you may be our new GCP Advisor Specialist?

Being part of Novo Nordisk Research & Development means working at one of the world’s largest and most successful biopharmaceutical companies.

Our R&D organisation is vital to Novo Nordisk and now we offer a talented person with an interest in clinical quality and process optimisation the opportunity to join us.

In Global Development, we take responsibility for new products based on proteins and peptides from early development phases to product introduction to the market. 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 a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.

About the department

The area R&D Quality is divided into three departments. The open position is as a GCP Advisor Specialist in the Global Clinical Processes & IT department. The department consists of 9 employees and we are responsible for deviations, serious breaches, vendor assessments, IT system quality, medical device support and act as QA function within R&D. We participate in cross organisational improvement projects and provide quality and GCP support to our global organisation.

The job
In close collaboration with your colleagues in R&D Quality, you will ensure that Novo Nordisk is in compliance with GCP and other relevant external and internal requirements in an optimal way without putting unnecessary burden on the organisation. You will be responsible for the GCP serious breach process and will evaluate and report serious breaches to the authorities.

You will perform assessments of our GCP vendors to ensure sufficient vendor QMS and you will enable great vendor management and sponsor oversight. You will provide GCP support to stakeholders globally and participate in cross-organisational improvement projects. You will be part of a dynamic department, where the position offers high impact and you are expected to take great ownership and responsibility and drive change and process improvements in the global organisation. Travel up to approximately 20 days a year is expected.

Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 10 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management/Monitoring, or GCP Audits is required.

You take a positive and pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player and you thrive working across departments in an international organisation.

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 change to be a part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Charlotte mannicke at +45 3075 3761 or Susanne Nørskov at +45 3079 8151

Deadline
02 august 2020. We will be screening and interviewing on an ongoing basis.

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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 7.7.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • Søborg
Rapportér

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