Dynamic team leader for Label and DFU Set-up team in R&D
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Måløv
- Clinical Development and Medical
- Måløv
Do you want to develop people and processes at the same time? Are you keen to join a dynamic organisation where the daily challenge is to ensure planning, set-up and approval of clinical trials labelling and direction for use (DFU)? Then this may be the right position for you.
About the department
Chemistry, Manufacturing and Control (CMC) Development is a part of the Research & Development organisation, manufacturing and distributing drug candidates for clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market.
Clinical Supplies Trial Set-up (CS TS) is part of CMC Development and is a key member of Research & Development and in bringing new drugs to market. In CS we have a unique understanding of the combination of drug development and supply chain management. Our main and most important task is to ensure that trial products are available on time and in the right quality and quantity for all clinical trials conducted by Novo Nordisk.
The position
As team leader for the Label and DFU Set-up, you play a key role in the department and lead a team of nine experienced and skilled professionals and administrative employees. The primary focus of the team is to prepare text, design and set up labels, obtain affiliate approval of label package and prepare DFU for Clinical Trial Application. In addition, the team has a strong focus on driving process optimization initiatives. It is your responsibility to ensure that our labelling and DFU processes comply with Annex 13 requirements and local requirements, and at the same time challenge local label requirements to keep our labelling process standardized and efficient.
In particular, you evaluate performance and set direction for the team both short and long term to ensure that all activities are planned and timely completed and in compliance with GMP/GCP standards. You focus on maintaining a high level of drive and commitment and, through visible leadership and sparring, you develop a culture where everyone is ready to challenge methods, systems and processes and continuously make them better, smarter and faster.
Qualifications
Ideally you:
- have a MSc or other degree in a relevant field (e.g. engineering, chemistry, pharmacy).
- have 3-5 years of experience within the pharmaceutical industry, health authority requirements, solid knowledge of Good Manufacturing Practice (GMP) and/or Good Clinical Practice (GCP)
- have experience with change management and LEAN tools.
- are fluent in Danish or another Scandinavian language
People management and project management experience is an advantage.
As a person, you have:
- a proven ability to inspire and motivate others
- drive to empower a team to deliver high quality results
- solid collaboration and communication skills
- a structured approach to your work and the ability to set the scene and give direction
Contact
If any further information is needed please contact Ditte Johansen on +45 3075 5462
Deadline
8th of December 2019
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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 25.11.2019, 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.
- Afdelingsleder
- Måløv
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