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- ...Managing daily operational activities for regulatory submissions including timeline management scheduling formatting publishing quality control archiving and submission to Health Authorities. Leading electronic publishing efforts for Investigational and Marketing...
- ...supporting role for other important Quality Systems like CAPAs Change Controls Deviations and Supplier Management. You will join a team... ...quality processes; such as CAPA management Deviation handling Change Control Supplier Management etc. Development- and training of users...
- ...a plus. (Be specific about your experience in your application.) Experienced within injection devices (ISO11608-1&2:2022) design control and drug-device combination product legislation (ISO13485 MDR 21 CFR Part 820 and 4). Experience with change control deviation and...
- ...filtering adjustments and configuration baselines. Flag actively exploited CVEs track remediation progress and suggest compensating controls where patching lags. Propose threat hunts initial detection opportunities and draft low-noise rules. Assist red/purple teams...
- ...and the wealth of the Novo Nordisk Foundation one of the worlds largest philanthropic enterprise foundations. Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. In...
- ...samples between CMOs. Responsible for assuring that studies data and related documentation (e.g. CMO created deviations change controls protocols reports) are archived in Ascendis Quality and document system. Together with the SME maintain the overview and assure...
- ...concepts such as VNETs/VPCs subnets routing private endpoints and secure service-to-service communication. Authentication and access control: Experience configuring modern identity and authentication mechanisms (e.g. Azure AD/Entra ID OAuth2 OIDC) for securing...
- ...standardization and cross-functional collaboration across departments. Advise on best practices for process improvement document control regulatory submissions and training management. Support roadmap planning and prioritization for future Vault enhancements....
- ...Hellerup. Make your mark as Fund Oversight Senior Specialist on our Trust & Depository EMEA team where youll drive end-to-end controls that safeguard billions in client Fund Oversight collaboration is everything: youll work side-by-side with a close-knit group that...
- ...starting materials intermediates and APIs including technology transfer process validation (PPQ) post PPQ optimizations risk management control strategies and continuous process verification programs (CPV) Trouble shooting activities together with CMOs including Deviation...
- ...Support in implementation of Pillar II and CBC reporting. Support in maintaining awareness of and duly implementation of Tax Control Framework and tax-relevant policies. Manage corporate tax audits globally. Qualifications and Skills: You hold a relevant...
- ...relational databases You have some understanding of Basic DAX Power Query (M) and Power Fx You know your way around version control tools such as CI / CD Git DevOps What we offer Business Analytics is our internal BI function responsible for both the...
- ...are responsible for all external financial reporting internal controls and group controlling in the Ascendis Group. The team you will... ...improvements and automation Support maintenance of internal control programs Assist in coordinating and planning team tasks and...
- ...Greater Copenhagen – we are looking for an experienced Head of Controlling. The company is growing fast and needs a financial leader... ...reporting in your area. You will lead a team of regional controllers and will play a vital role in preparing the Group's financial...
- ...ind i rollen ser vi gerne, at du har følgende kvalifikationer: ~+5 års erfaring enten fra en finansfunktion – fx som revisor, controller, finance business partner eller fra et ERP-hus som ERP-konsulent, udvikler eller projektleder krydret med relevant finanserfaring...