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Denmark

Industry consultant for end-to-end business strategies, processes and implementation of solutions for electronic standardized data from small laboratories to large pharma companies.Data conversion and submission compliance support.Specialist in:- CDISC SEND compliance- eSubmisison requirements- Process design and improvement in nonclinical data life cycle- Software selection and deployment- Data conversion and terminology mapping (SDTM & SEND)- Training (authorized CDISC instructor; see www.cdisc.org)

Denmark

Responsible for data management, including the technical coordination of data capture from nonclinical studies within development projects at Novo Nordisk.- Defining IT architecture and strategy- IT solution description and URS- System testing- Defining data dicitonaries and mapping- Process and workflow descriptionsLeader of Nonclinical Standardization.- Data standards expert (interpretation and education)- Defining internal data standards- Data standards governance

Copenhagen Area, Denmark

• Accountable for non-clinical IT project execution.• Responsible for ensuring that NN receives a solution that delivers the benefits described in the project agreement.• Responsible for ensuring project adoption and business transformation for NN including identification of training needs and associated planning.

Copenhagen Area, Denmark

Regulatory Affairs - Development projects, Hemophilia- External communications task-force for pegylated products- Planning and preparation of submissions activities to national health agencies, EMA and FDA;- Review of CTA/IND dossier; non-clinical and clinical documentation incl. Investigational Medicinal Product Dossier, Investigators Brochure and module 4 reports.- CTA/IND submissions globally- Coordination and compiling responses to national health agencies, EMA and FDAOther- Submission of clinical bioequivalence data in Canada- PIP applications (EU)- Orphan drug applications - Scientific Advice briefing packages (EMA and FDA)- Planning and coordinating project tasks- Optimisation of internal processes

Copenhagen Area, Denmark

Main job function: Project toxicologist* Responsible coordinator for all aspects of toxicology* Working with central laboratories in the conduct on nonclinical studies* Preparation of documentation according to eSubmission standards recommended by the FDA, including eCTD requirements, CDISC standards and the Study Data Specification guidance.Specific competencies: * Carrier mediated delivery of biologics* Safety assessment of excipients and inactive ingredients* Carcinogenicity dataset* Knowledge of electronic submissions, incl. eCTD and CDISC SEND.

Master Of Science With Distinction, Applied Toxicology

Modules: Principles of Experimental Toxicology and Risk Assessment Inhalation Toxicology Paediatric Toxicology Carcinogenicity.

Cand. Scient, Biology

Final Thesis: Hibernation among landliving vertebrates