stillingsbetegnelse:
Pharmacien spécialisé / Pharmacienne spécialisée en législation pharmaceutique

jobbeskrivelse:

DOC2016 Experienced regulatory professional with a scientific background combined with several years of regulatory experience to support our activities related to submissions & approvals of a new oral GLP-1 & interactions with Health Authorities. Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. member of cross functional project teams including study groups and submission teams. participate in review of clinical trial protocols & reports as well as development of regulatory documentation for submission to health authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, safety reports & finally regulatory file for marketing authorization. interact with medical & non-clinical specialists, statisticians and medical writers. university degree in science complemented by a PhD and have 4-6 years of experience from regulatory affairs or other relevant departments in pharma industry.

Leader sur le marché mondial de la diabétologie, Novo Nordisk est un laboratoire pharmaceutique international avec 41 000 salariés dans 75 pays. Regulatory Affairs (RA) Oral GLP-1 & Early Diabetes Projects are responsible for development projects within treatment of diabetes and diabetic complications. We drive label development, Health Authority interactions and clinical trial applications

Leader sur le marché mondial de la diabétologie, Novo Nordisk est un laboratoire pharmaceutique international avec 41 000 salariés dans 75 pays. Regulatory Affairs (RA) Oral GLP-1 & Early Diabetes Projects are responsible for development projects within treatment of diabetes and diabetic complications. We drive label development, Health Authority interactions and clinical trial applications

Timer per uge: 40:00

Job kort beskrivelse: Sundhedsarbejde ikke klassificeret andetsteds

land: Danmark

region: DANMARK

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Højere uddannelse, inklusive akademisk

Erfaringer: Mellem 2 og 5 år

Kilde til jobtilbud:
Pôle Emploi, Offentlige arbejdsformidlinger, Frankrig

Hvordan søger: Andet - se fritekst