Global Clinical Regulatory Affairs Specialist

In-depth experience with clinical submissions for multiple countries, such as Sweden, Germany, Switzerland, UK, the Nordics

Excellent project management skills working with foresight, keeping relevant stakeholders in the loop, and taking initiative

Working independently in a team with a self-starter mentality

Supporting various clients with their Medical Device (MDR), pharmaceutical (CTIS), and In Vitro Diagnostic (IVDR) studies

Supporting them with Clinical Regulatory activities such as, but not limited to the submission to authorities and central Ethical Committees and creating and writing Informed Consent Forms and contract–budget negotiations

Multinational work (Sweden, Norway, Denmark, Finland, Germany, UK, and Switzerland)

Study Start-Up Manager activities and responsibilities connected to clinical/regulatory study start-up in Sweden

Organizing and planning IRB/IEC submissions, finalizing patient-related documents, budget and contract negotiations, pharmacy agreements, and biobank submissions

Attending and leading local study meetings

Having close communication and relationships with healthcare professionals

Managing the submission package for IRB/EC and regulatory agencies including 8 different countries in the Nordic and Baltic region

Including tracking of Case Report Forms, queries, and data. Reviewing site-specific Informed Consent Form (ICF)

Reweaving and summarizing protocols

Setting up the complete submission package for Sweden, Finland, Denmark, Norway, Lithuania, and Latvia

Acting as the central role for the designated project communications, correspondence, and associated documentation

Organizing meetings, creating, and tracking study memos/letters, and preparation of the investigator’s meetings