Senior Scientist Clinical Research
il y a 3 jours
Wij hebben een zeer interessante positie open voor een
**Senior Scientist Clinical Research - Clinical Supplies Specialist**
**Over de functie**
De persoon is verantwoordelijk voor de organisatie en opvolging van alle activiteiten in verband met studie medicatie en/of apotheek bereidingen voor fase 1 studies.
**Primaire verantwoordelijkheden**
- Planning en begeleiding/toezicht van alle kritische aspecten van clinical supplies management bij het opzetten en uitvoeren van fase 1 studies in diverse therapeutische gebieden.
- Samenwerking met onderzoekers, staff van fase 1 sites, ziekenhuisapotheken, externe vendors en HQ stake holders voor clinical supplies activiteiten, waaronder-input in opzetten en bereiden van on site formulaties/bereidingen,-unblinded activiteiten zoals controleren van drug allocation schedules, superviseren van eerste dosering, opvolgen van drug accountability en/of complaints
- Opvolgen van clinical supplies gerelateerde taken met clinical study sites/vendors waaronder bijhouden van Technical&Quality agreements, ondersteunen van GMP audits voor clinical site/vendor qualificatie en opvolgen van CAPA’s
- Kennis van de regulatory vereisten betreft clinical supplies management bij het uitvoeren van fase 1 is een pluspunt.
**Jouw profiel**
De positie vereist een “farma gerelateerd diploma” (MD, PharmD, MSc or PhD in Farmacologie of Biomedische Wetenschappen). Zeer goede communicatieve vaardigheden, goede relationele vaardigheden om in teams te werken alsook ervaring met early stage development zijn een pluspunt. Business travel kan nodig zijn om de projectactiviteiten op te volgen
Kandidaten moeten vloeiend in Nederlands en Engels zijn.
**Wie we zijn**
In de Verenigde Staten en Canada staan we bekend als Merck & Co., Inc., Kenilworth, New Jersey, VS, en in alle andere landen als MSD. Al meer dan een eeuw stellen we ons in dienst van het leven en produceren we geneesmiddelen en vaccins voor veel van de meest uitdagende ziekten in de wereld. Ook vandaag de dag blijft ons bedrijf voorop lopen in het onderzoek naar het leveren van innovatieve oplossingen in de gezondheidszorg en het op een hoger plan brengen van de preventie en behandeling van ziekten die een gevaar vormen voor mensen en dieren wereldwijd.
**Waar we naar zoeken**
Stel je eens voor dat je iedere ochtend opstaat voor een baan die net zo belangrijk is als het redden en verbeteren van levens over de hele wereld. Bij ons krijg je die mogelijkheid. Je kunt je empathie, creativiteit, digitale skills of jouw wetenschappelijk meesterbrein aan het werk zetten. Dit doe je samen met een groep van uiteenlopende collega’s die als gezamenlijk doel hebben om hoop te geven aan talloze mensen die knokken tegen enkele van de meest uitdagende ziekten van onze tijd. Ons team ontwikkeld voortdurend, dus behoor jij tussen de knappe koppen, sluit je dan bij ons aan en begin vandaag nog jouw impact te maken.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular**Relocation**:
No relocation**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R168483
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