Junior accountant állások, munkák törzskönyvezés kategóriában

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

Állatgyógyászati termékek regisztrációs dossziéjának II. részének (Part II) szerzői és szakmai elkészítése, strukturált átírása és naprakésszé tétele a hatályos EU-s és hazai előírások szerint....

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Provide support to complete product dossiers, technical files and responses to information requests
• Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
• Work with project teams to obtain approval for company products

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery...