stillingsbetegnelse: Project Manager

jobbeskrivelse:
. Regulatory Affairs . Denmark - Søborg Are you strong at project management, do you have a good understanding of the dynamics in the Pharma Industry and would you like to drive the implementation of the new EU Clinical Trial Regulation in Regulatory Affairs and coordinate implementation activities across the Novo Nordisk organisation? Then you might be the Project Manager we are looking for in Global CTA Management. About the department The Global CTA Management department in Søborg is part of Regulatory Operations in Regulatory Affairs and works closely with stakeholders in Clinical Operations, Clinical Pharmacology, the Regulatory Affairs project teams and Regulatory and Clinical in the affiliates. We are a team of 11 highly motivated and engaged employees. We are responsible for coordination and planning of the assembly of the document packages for Clinical Trial Applications to Health Authorities and Ethics Committees, in order to support the authorisations to conduct the growing number of clinical trials in Novo Nordisk. Global CTA Management is a department in constant development, since it was established 2 years ago; it therefore offers interesting and challenging assignments and opportunities for continuous personal and professional development. The job As Project Manager in Global CTA Management your primary task will be to drive the project implementing the new EU Clinical Trial Regulation in Regulatory Affairs, and to align activities and project plans across functional areas in the Research and Development organisation in Novo Nordisk. The job offers senior management interactions, leadership responsibility and has cross organisational and international reach. Your job will be to set the right direction for the project and your project team, at the same time, making sure that the impact of the EU Clinical Trial Regulation is analysed in details, that a full impact assessment on how RA processes will be affected is conducted and that new process flows are developed, implemented and anchored in the organisation according the project plans and timelines. You will be responsible for ensuring that relevant stakeholders inside and outside Regulatory Affairs are involved when appropriate and you will have the communication and change management responsibility before, under and after the implementation of the regulation. Qualifications You have completed a relevant Master's Degree with excellent results - and have backed your theoretical background with at least 5 years’ practical Project Management experience within the Pharma Industry. You have a solid track record of handling complex cross organisational projects and you have acquired solid experience using and applying classic project management tools. Knowledge about Regulatory Affairs and/or Clinical Development is an advantage. You are comfortable interacting with stakeholders at any organisational level and you are used to work across organisational and geographical boundaries. Leading others in project contexts comes natural to you, and you use your energy and understanding of other people to involve the right competences in the right processes and carry projects ideas through with success. You have a high level of drive, initiative and persistence and you are result-oriented. In addition, you are ambitious and like to be challenged. You are analytical, structured and comfortable managing a project team on your own. The atmosphere in Global CTA Management is informal and humorous. While we expect everyone to do their best every day, we also like to have a laugh together. If you feel the same way, you are the kind of person we are looking for. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please call Marianne Myhre

Arbejdsgiver Navn: NOVO NORDISK A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse:
Ledelse inden for anden forretningsservice og andre administrative funktioner

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark