Digital project menedzser állások, munkák minőségbiztosítás kategóriában

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Lead and coordinate CMC development activities for innovative small molecule anti-infective drug candidates
• Drive late-stage CMC readiness for key clinical and regulatory milestones, including Phase 3 preparation

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)...

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)...

Acting as subject matter expert for global Quality applications (e.g. Veeva QualityDocs, Veeva QMS, LIMS and related systems), ensuring they remain compliant, user-centric, and fit for purpose....

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...

• Ensuring EPR compliance (WEEE, VerpackG, BattG) for Leica Microsystems, including registration and reporting in relevant markets. • Responsibility for action plans and coordination of cross-functional activities (e.g. workshops, Kaizens, daily management). • Guiding of departments in implementing...

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities