Outsourcing Project Manager
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Måløv
- Research
- Måløv
Would you like to take part in an exciting project, working across countries, and spanning several areas of our organisation? Are you passionate about scientific project management? And do you have experience with outsourcing? Then you may be the person we are looking for!
The department of Clinical Bioanalysis is seeking a highly scientifically qualified and proactive project manager for a new position with responsibility for outsourcing of bioanalysis of drugs and anti-drug antibodies to Contract Research Organisations (CROs) in China.
About the Department
The department is responsible for bioanalytical support for clinical safety and efficacy evaluations across the entire project portfolio at Novo Nordisk A/S in support of clinical research and/or marketing applications. The department is one out of 5 within Non-clinical and Clinical Assay Sciences (NCAS) that covers both bioanalysis and immunogenicity assessment and is located in Måløv, Denmark.
You will work alongside 15 dedicated colleagues. We are passionate about our work and appreciate a working environment with good discussions and humour. It is our ambition to support the organisation by delivering good science.
The Position
We are currently embarking on a journey, outsourcing a number of our clinical assays to CROs in China, to ensure that our clinical trials will run as smoothly as possible, to the benefit of our patients.
It will be your responsibility to ensure outsourcing of both PK and ADA clinical assays to Contract Research Organisations (CROs) in China. Your main focus will be ensuring that the clinical assays are available in China CROs, at the right time and in the right quality. This includes identification of suitable CROs, setting up contracts for validation of assays and ensuring transfer and validation of assays from Novo Nordisk to the CROs, Hence, a number of travel days per year must be expected.
You will support several projects across the portfolio and function as the coordinator in close cooperation with the bioanalysis and immunogenicity specialists, clinical trial managers, regulatory affairs, Outsourcing Management and our Chinese affiliate.
Qualifications
You have a Master’s degree within Life Science (e.g. Biology, Biochemistry, Pharmacy, Biotech Engineering etc.) and a PhD degree or equivalent experience within a relevant field preferably working with development and validation of bioanalytical methods (LC-MS/MS and/or immunoassays (ELISA, RIA, MSD, AlphaLISA)).
Insight in clinical development from an outsourcing management perspective and knowledge of the regulatory guidelines and the GLP/GCP principles is an advantage.
You have strong project management skills and are excellent at communicating written and orally in English and building fruitful relations to both colleagues and stakeholders in a multidisciplinary environment.
As a person, you have a strong quality mindset, you are flexible and ambitious. You work independently, take responsibility and enjoy handling many complex tasks.
Contact
For further information, please contact Cecilie Freddie Lange at +45 3079 4908.
Deadline
01 March 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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 10.2.2020, 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.
- Afdelingsleder
- Måløv
- Søndag den 01. marts 2020
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