Farmaceuter til Regulatory Affairs

4 weeks ago

København, Denmark Targeting vJeanette Juhlin Full time

med flair for marketing compliance - evt. med mulighed for deltid (min. 30 timer)

LINK Medical søger hurtigst muligt 2 Regulatory Managers med interesse for og meget gerne erfaring med Regulatory Affairs. Stillingen byder på et bredt udvalg af opgaver, og du vil også få mulighed for at arbejde med marketing compliance.

LINK Medical er en konsulentvirksomhed med skandinaviske rødder - en dynamisk arbejdsplads der lægger vægt på tillid, åbenhed og medbestemmelse. Her har du som medarbejder indsigt i ”hele forretningen”, og alle kender hinanden og samarbejder på tværs af organisationen om de fælles mål. Vi er i dag 25 medarbejdere tilknyttet kontoret, der ligger på Strøget i København.

Som Regulatory Manager arbejder du tæt sammen med kunder og samarbejdspartnere. Du kan i perioder arbejde på vores kunders kontorer rundt omkring i Storkøbenhavn. På den måde sikrer vi vores kunder den bedste rådgivning, og som ”leverandører af rådgivning” er vi med, der hvor det sker. For at sikre det fortsatte tilhørsforhold til LINK og kollegerne, har vi faste, ugentlige kontordage og ”LINK-dage” ca. en gang om måneden, hvor vi udveksler erfaringer og viden, lærer nyt og hygger os i hinandens selskab.

Opgaverne omfatter bl.a.:

Compliance review af marketingaktiviteter og -materialer for den farmaceutiske industri og anmeldelser til Etisk Nævn for Lægemiddelindustrien Oversættelser af regulatoriske og medicinske dokumenter (dansk/engelsk) Andre regulatoriske opgaver svarende til opgaverne i et dansk datterselskab: gennemgang og opdatering af produktinformation, regulatorisk review af artwork, uddannelsesmaterialer, variationer m.m. Rådgivning af virksomheder inden for det regulatoriske område (post-marketing) Kontakt med regulatoriske myndigheder og andre eksterne partnere.

Kvalifikationer:

Farmaceut eller cand.med. Et par års erfaring (helst) inden for Regulatory Affairs og kendskab til relevant europæisk lægemiddellovgivning og guidelines Erfaring fra konsulentbranchen vil være en fordel Dansk og engelsk på højt niveau – både mundtligt og skriftligt - da du skal kommunikere med kunder og offentlige myndigheder i både ind- og udland Dygtig IT-bruger

Som person er du fleksibel og positiv, og du vil gerne bidrage til både gode resultater og et godt samarbejde. Du er omhyggelig og struktureret og foretrækker levere dine opgaver i en høj kvalitetsmæssig standard. Selv i en travl hverdag kan du hæve dig op og levere strategiske oplæg til opgaveløsning og sideløbende oversætte produktinformationer eller lign. og løse mere rutineprægede RA-opgaver. Du trives kort sagt med varierede opgaver.

LINK Medical tilbyder:

En konkurrencedygtig løn og pension en spændende og udfordrende stilling i en nordisk CRO/konsulentvirksomhed gode interne udviklingsmuligheder

Ansøgning/CV: sendes til Targeting Personalerådgivning, der hjælper med denne rekruttering, til jj@targeting.dk - gerne hurtigt, da vi løbende indkalder kandidater til samtale. Kontakt evt. Jeanette Juhlin, Targeting Personalerådgivning, på mobil 4075 0202 for yderligere information.

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