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2 Regulatory and Marketing Compliance Managers
Har du interesse for og meget gerne erfaring med Regulatory Affairs – og helt optimalt med Marketing Compliance – og vil du gerne arbejde mere målrettet med Marketing Compliance?
Dine arbejdsopgaver bliver 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 m.v.
Specialist, Regulatory Affairs (Temporary Position)
As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.
Further, your main responsibilities include to:
- Gather information and documentation for variation applications
- Update dossier sections
Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.
The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.
You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.
QA Specialist
You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.
You will have the opportunity to:
- Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
- Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.
Senior International Medical Manager
Are you a Medical Doctor with an interest in clinical development of pharmaceutical drugs, medical devices and digital health?
Trial Manager - Clinical Development Centre Denmark
Are you passionate about management of clinical trials and would like to be part of the patient’s life change?
Senior Director, Portfolio Regulatory Policy
Are you passionate about shaping future regulatory frameworks and policies?
Clinical Data Standards Specialist
Do you want to work with standardising data in clinical trial?
Medical Scientific Liaison Renal Acute
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company.
Development PKPD Specialist
Are you a scientist with flair for mathematical modelling and knowledge of pharmacology, biology or physiology?
Upstream Support Specialist
Would you like be responsible for providing technical assistance within process design and process documentation?
Senior Director in Data Orchestration
Can you make a difference in drug development through data?