Arbejde Regulatory Senior Associates Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Regulatory Senior Associates

jobbeskrivelse:
- Administrative - Denmark - Søborg Our growth is your opportunity 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's continued growth and we always welcome talented people who would like to grow with us. Novo Nordisk Regulatory Affairs is seeking an experienced Regulatory Associate for our team in Søborg, Regulatory Affairs Victoza®. If you thrive in a dynamic and challenging environment with focus on regulatory execution, this job offers you the opportunity to be part of the regulatory submissions of the Victoza® LEADER® cardiovascular outcome trial. About the department Regulatory Affairs Victoza® works with Victoza® our blockbuster GLP-1 agonist for treatment of type 2 diabetes and with other liraglutide projects for treatment of diabetes. Our responsibilities include outlining the regulatory strategies, interacting with regualtory authorities and managing the regulatory submissions to obtain and maintain marketing authorisations worldwide for Victoza®. We have a project centric organisation and you will work in cross-functional teams. Our key external stakeholders are the regulatory authorities. The job You will be responsible for managing the compilation of the dossiers supporting the Victoza® LEADER® submissions. Part of your everyday work will include quality check of documents for regulatory submissions, and compiling and archiving of electronic documents into our global document management system. One of your key tasks will be quality checks before the dossiers are submitted to the authorities. Thus, administrative duties and IT systems support will be part of your everyday task. We work with several very different submissions, and thus, you need to be able to handle several tasks at the same time. This requires good coordination and planning skills, accountability and the ability to work under tight deadlines including high workloads in periods. You will be a key player in keeping track of timelines and deliverables. You will work closely together with other regulatory associates and regulatory professionals on the regulatory submissions. In addition, you will be the point of contact for our colleagues in other countries and assist them with for instance submission support. Qualifications You hold a bachelor’s degree in business administration, English or science. You must have at least five years of administrative experience from regulatory affairs including experience with managing major submissions worldwide. You have experience with professional use of IT systems such as electronic document management and you are proficient in the Microsoft Office package. You are proactive and like to work independently, as well as in a team. You are flexible, are able to work under tight deadlines, have a strong quality mindset and a sense for details. Good coordination and planning skills and an excellent command of written and spoken English is a must.Your communication skills ensure that you can work across different cultures and skill areas. In addition, you have demonstrated that you can plan, keep track on timelines and ensure that the regulatory team delivers regulatory dossiers of high quality. Learn more about us: novonordisk.com/RD-careers At Novo Nordisk, we work together to prevent, treat and eventually cure diabetes. Nearly 317 million people worldwide are living with diabetes today, with two people diagnosed with the disease every ten seconds. Working here is not just a way to make a living, but a way to make a difference Contact For further information, please call Lene Melchiorsen on +45 3075 1993. Deadlines 19 January 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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