Overseeing clinical trials and accountable for the end-to-end planning, execution and completion of clinical trials.Responsible for managing trial projects, assuring timely deliverables throughout the trial life cycle, and leading Trial Squads (study teams) to ensure optimal trial progress and project advancement.Identify project risks, prevent and/or respond to isses, and decide on resolutions.Engage and communicate with various stakeholders, project management, and assess quality, compliance and retention of data for succesful product development.

Clinical development• Leading the clinical evidence/data strategy for intraoperative ultrasound within HPB (hepatic/pancratic/biliary). • Crossfunctional collaboration (primarily marketing, clinical, regulatory, engineering)• Mapping Clinical interdependencies and coordinating work between projects• Driving clinical activities in innovation projects• Wording and substantiation of clinical claims (marketing material)• Process and documentation optimization

Clinical affairs• Dissemination of medical information to different stakeholders• Medical writing (clinical evaluation documentation)• Clinical contribution in innovation projects• Crossfunctional collaboration (primarily marketing, clinical, regulatory, engineering, QA)• Process and documentation optimization projects

Regulatory affairs• Project lead for interpretation, composing and implementing procedures and clinical documentation to make company products compliant to the Medical Device Regulation (class III medical devices and combination products).• Collaboration with stakeholders in all parts of the company to secure cross-functional coordination around PMS activities and analyses and reporting thereof.• Worked in product innovation projects.• PMS network member (Medicoindustrien).

The committee´s task was to support LIF with expert assistance and to advise on strategic priorities and politics in relation to the business´ ethical and compliance agenda. The work done by the committee supported LIF´s strategic objectives on strengthening the collaboration with stakeholders.

Medical affairs• Ensured medical and scientific accuracy (promotional, HCP interactions and patient material) and compliance with company Policies, Procedures and Ethical Standards as well as compliance with the local Pharmaceutical Industry ethical code and other applicable rules and regulations.• Responsible for the continuous education of coworkers on pharma compliance.• Project lead for implementation of several digital initiatives.• Marketing compliance network member (LIF).

As a part of Nordic Medical Affairs, the position included providing medical and scientific services to local customers.Management of the local Medical Information vendor was a major part of the responsibilities (communication as well as training and quality assessments to ensure compliance and quality of service). I conveyed technical/medical information in an accurate, balanced and law compliant manner. Other tasks included:• Recognizing and forwarding adverse drug events and/or product complaints to Pharmacovigilance and Quality departments, and document accordingly. • Keeping up-dated and maintaining knowledge and awareness of company’s products, clinical research and current regulations• Providing training to field sales teams on current medical information request and dissemination policy• In collaboration with Nordic colleagues maintaining and developing SOPs and processes to ensure continuous improvement and compliance• Leading local vendor-meetings with relevant internal stakeholders to share information, align processes and to develop and improve current practice• Supporting the commercial organization with statistics and insights about product inquiries

The project included studies on rats and cells as well as human intervention studies and had the purpose to reveal underlying mechanisms in improved insulin sensitivity with an increased skeletal muscle capillarization. The methods used included hyperinsulinemic euglycemic clamp (rat and human), indirect calometri, biopsies, blood sampling and laboratory work such as ELISA and western blotting. I also worked with L6Glut4-Myc tagged cells to examine insulin-stimulated glucose uptake. I have presented the work at several conferences and scientific seminars.

Consultant for the Virtual Laboratory 2.0 developed by Biotech Academy. My role in the project was to expand the Diabetes area in the program. I was responsible for developing exercises that give a realistic insight to diabetes research. I also presented the program to high-school students/teachers and project stakeholders.The Virtual Lab is a free e-tool aimed at students in high school and the first years of university – or anyone with a special interest in biology and biotechnology. It was designed as a learning tool and simulates lab work in a realistic manner, thus teaching the user good lab practices and how to avoid typical pitfalls while the user’s knowledge of central biotechnological areas is stimulated.

Clinical trials: - Human trials including analysis of muscle biopsy and blood. - Microdialysis, EKG, DEXA scanning. In vivo and in vitro research:- Laboratory animal trials and work with primary cells. - Western blotting.- Immunohistochemistry

In vitro research:- Mammalian Cell Culture- ELISA- Western Blotting - I taught assay techniques in the course “Experimental Biology and Physiology”.

Communication:- Office tasks including customer service.- Communication with competing firms.

Project management:- Responsible for the start-up of a Swedish/Danish switchboard

Hospital work:- As a medical student I assisted the nurses in medical as well as psychiatric wards. Unpredictable work where it was important to keep a clear and organized mind in stressful situations. I also became familiar with the daily routines and basic examination methods in a hospital.