Copenhagen, Capital Region of Denmark, Denmark
I deal with the integration of economic and legal concerns, compliances and conflicts which businesses are confronted with, both from the perspective of private companies and the public sector.
• Provides legal counsel at Forskningsjura (Legal Department for Scientific Research) for all hospitals, health centers and the emergency medical services in The Capital Region of Denmark. • Reviewing, drafting, and negotiating research agreements (Collaboration, DPA, CTA, MTA, IIS, EU, DTA, NDA, SCC, Grant, Consordium, Disclosure, Service, Ph.d. etc) with national-, and international public-, and private stakeholders. • Providing legal counseling to researchers regarding data processing in accordance with GDPR. • Keeps records of research projects according to GDPR. • Legal Counsel in specialized areas: Trial Nation, Technical University Hospital of Greater Copenhagen (TUH), EU programmets, AI. • Developed and implemented new methods for risk asesssment / DPIA at the legal department • Teaches internal stakeholders in GDPR and contracting. • Carry out physical audits of data processors (according to ISO 2700x). • Develops and updates internal legal guidelines, templates etc. • Election Officer at the General election to the Danish Parliament & European Parliament (voluntary).
• Tracing of Covid-19 infected individuals and their close contacts. • Provided guidance on isolation, vaccines, test requirements, etc. • Registration of the citizens information.
• Regulatory Affairs Assistant at H. Lundbeck A/S through ProductLife Group. • Contribute to regulatory activities performed on the RA Platform (EDMS and Sharepoint). Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers • Transfer of data from acquired companies to Lundbeck's database. • Contribute to the production of client administrative documents to be included in regulatory submissions • Compile regulatory dossiers in accordance with national requirements. Systems Management and Administration • Document and track regulatory submissions and regulatory authority approval. Provide regulatory support to clients and associate companies. • Liaise with sponsor head-office and affiliate departments on regulatory issues. • Liaise with external regulatory authorities as required. • Provide review of packaging texts. • Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check). • Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives. • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
• Class teaching in EU-law at the BSc. programme in Business Adm. & Commercial Law, at CBS Law Department. • Helping to ensure that the students can explain the structure, functions and regulation of the EU, in particular the working methods, practices and principles of interpretation of the European Court of Justice, that the students can identify legal arguments based on the curriculum and that students can place concrete issues in an EU legal context. • Providing feedback on written assignments.
• Corporate Student Worker at the Department of RNA Therapeutic Research. • Managing accountings and the company ́s contract database. • Ad hoc work.