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- ...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 that data...
- ...Promote 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....
- ...domains URLs) with context (first-seen ASN geo confidence). Document findings and escalate complex samples/problems to senior analysts... ...CVEs track remediation progress and suggest compensating controls where patching lags. Propose threat hunts initial detection...
- ...important Quality Systems like CAPAs Change Controls Deviations and Supplier Management. You... ...management Deviation handling Change Control Supplier Management etc. Development-... ...the electronic QMS Veeva Quality Vault Document Control Management of GxP documents at...
- ...Ascendis Pharma team you will play a crucial role in maintaining documentation according to changes of the product production setup and... ...Experienced within injection devices (ISO11608-1&2:2022) design control and drug-device combination product legislation (ISO13485 MDR...
- ...scheduling formatting publishing quality control archiving and submission to Health... ...plans trackers and timelines. Preparing documents across all disciplines (e.g. CMC nonclinical... ...Project) Word Templates and regulatory document publishing tools (Adobe Acrobat ISI...
- ...process validation (PPQ) post PPQ optimizations risk management control strategies and continuous process verification programs (CPV)... ...release of batches together with QA Writing of regulatory documentation for marketing approval and post-approval Qualifications and...
- ...Deep knowledge of global regulations and industry standards Experience in managing disclosure systems and processes including document redactionandanonymizationapproaches Excellent attention to detail and ability to handle sensitive information Provencommunicationstakeholder...
- ...exposure ~ Help improve templates QA checklists and process documentation. ~ Master data maintenance (market codes SKUs partner... .../quarterly deadlines. ~ Are a clear communicator who can document issues and follow them through. ~ Arefluent in English (written...
- ...benefit people and society. Your tasks will include: Collecting and coordinating input from across the Foundation to prepare documents and presentations for the Foundations Board of Directors and Portfolio Board Analysing and translating large data sets into...
- ...scientific Support: ~ Assist with the preparation collection and formatting of medical materials including slide decks briefing documents Project Coordination and Documentation ~ Help coordinate medical affairs projects by scheduling meetings preparing agendas...
- ...events with partners and internal teams Maintaining accurate documentation of partnership activities We hope that you will bring your... ...CV cover letter university transcripts and other relevant documents by clicking the Apply now button no later than 20 November. We...
- ...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...
- ...Management System (LMS) and Adobe Sign: ~ User requests access requestsquestionsetc. ~ Incidents ~ Participate in structuring documenting and anchor the support flow and build/maintainthe knowledge bases ~ Support with quarterly SOX review and other compliance...
- ...across frontend and backend technologies contributing to system architecture containerised environments and clear maintainable documentation Improve developer and user experience by shifting quality left applying strong design principles and delivering minimum viable...
- ...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...
- ...patientsyou should look no further than Ascendis Pharma! This isa great opportunityto learn how to create andmaintaina high quality of documentation in aglobal biotech. Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in...
- ...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...
- ...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...
- ...timely collection and delivery of GxP shipments Communicate clearly and accurately with third-party vendors Compliance & Documentation: Develop and maintain SOPs work instructions and shipping-documentation Ensure all transportation and storage activities comply...
- ...Facilitate and support analytical performance and efficiency improvements at CMOs and internally at Ascendis Writing of regulatory documentation and follow-up on post-approval commitments to authorities Qualifications and Skills: You hold a relevant academic degree...
- ...junior sparring partner and help prepare materials for leaders on finance topics. Support optimisation of finance processes and documentation. Help run our planning forecasting and performance management cycles and contribute to area-specific projects and business...
- ...applications as well as participate in scientific conferences. ~ Formulate the content of reports recommendations and other written documents in a concise and professional manner. Professional and personal qualifications We are looking for a scientific team-member...
- ...working knowledge of FDA and EMA pharmacovigilance regulations ICH Guidelines and other relevant global safety regulations and guidance documents. Key competencies: You are a strong team player analytical and have a can-do attitude. You possess an entrepreneurial...
- ...the assistance of your Talent Success Coach, you can accept the classes that match your schedule and preferences. You have complete control over your agenda, and we don't require a minimum number of hours per week or month. Job Information: Individual and group...
- ...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...
- ...Provide leadership to teams of medical monitors Provide leadership to study teams Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study...
- ...running of two neuroimaging studies with high international impact. You will carry out MRI data collection of patients and healthy controls, ensuring successful data collection, and apply your research expertise to the project. There will also be opportunities to become...
- ...Collection & analysis of client requirements and business processes, Documentation, mapping the requirements and proposing suitable changes in... ...‘to-be’ Create documentation i.e., Functional requirement Document (FRD), Functional Design Documents (FDD), configuration...