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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...
- ...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...
- ...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...
- ...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....
- ...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...
- ...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...
- ...external financial reporting internal controls and group controlling in the Ascendis Group... ...will include: Prepare templates and documentation for financial reporting including... ...automation Support maintenance of internal control programs Assist in coordinating and...
- ...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...
- ...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...
- ...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...
- ...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...
- ...oversight on complex troubleshooting automation and proactive remediation scripts to ensure operational excellence. Driving documentation knowledge sharing and training initiatives within the team to elevate overall endpoint management maturity. Qualifications...
- ...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...
- ...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...
- ...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...
- ...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...
- ...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...
- ...analytics to support key business decisions ~ Stay current on key publications (e.g. scientific literature analyst reports regulatory documents) and share findings with key stakeholders ~ Contribute to special projects or operational initiatives as needed (e.g. patient...
- ...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...
- ...extractables and leachables and endotoxin thresholds Calculation and documentation of PDE and OEL values and Occupational Health Categorization... ...DP and DS specification limits including input to regulatory documents Collaborating on QSAR assessment reports Set-up and...
- ...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...
- ...YORVIPATH. The position is based at our headquarters in Hellerup Denmark. Your support tasks will be: Maintaining and managing Document Management in Veeva and Teams Assisting with the creation and management of purchase orders work orders and contracts for both...
- ...any emerging safety concerns via signal management process. To ensure that the conduct of PV and submission of all PV-related documents are in accordance with the legal requirements and GVP. As the head of QPPV office lead the QPPV team to fulfill specific tasks...
- ...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...
- ...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...
- ...possible and no later than November 9 2025. To apply please send your CV cover letter university transcripts and other relevant documents by clicking the Apply now button. About The Novo Nordisk Foundation The Novo Nordisk Foundation dates back to 1922 and is...
- ...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...
- ...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...