Fi With Gjessø Email & Phone Number

Copenhagen, DK

Ensuring that all Clinical Trial Applications in Novo Nordisk is handled efficiently and with high quality.

Søborg, Denmark

Global regulatory life cycle management responsibility, incl RA project lead for a device optimisation project in more than 90 countries.

Leading regulatory department and activities in Denmark

• Leading Clinical Operations in Denmark
• External stakeholder management to support clinical trial framework conditions

• 20% of my time, in parallel to Head of Clinical Operations role with a dotted line reporting to Director for Corporate Affairs.
• Support and advice to GM and Board of Directors on significant work areas
• Contributing to the execution of the overall strategy of GSK in Denmark
• Support GM on external activities (non-policy oriented)Projects, e.g. was responsible for closing the stategic partnerships deal, with KU and "Region Hovedstaden" and starting up the collaboration - see link below.

Supervisor for the Danish medical department (2 CRA’s and 1 secretary)Beyond this, responsibility for initiation and monitoring of clinical trials within different therapeutic areas.

Responsibility for all regulatory issues in Denmark and Iceland. The working tasks included pharmacovigilence, product complaints, pharmaceutical information and submission and labelling of clinical trials.

Sales representative at general practitioners, pharmacies and the hospitals in my district. I was working within cardio-vascular, diabetes and anti-infective.I was working in a 50% position in parallel to the regulatory affairs position.

Responsibility for all regulatory issues in Denmark and Iceland. The working tasks included pharmacovigilence, product complaints, pharmaceutical information and submission and labelling of clinical trials.