The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use have identified an issue across the biopharmaceutical industry regarding a trend that companies are allocating too few resources towards aligning actual employee competencies with the ones documented for authorities.

This thesis investigates which challenges and opportunities are connected to aligning the documentation of and possession of competences in organisations that are subjected to authority regulations. The thesis is then based on the assumption that in order to ensure employee competences there is a need for a professional instructional design and execution. Therefore the study has been primarily focused on the development, testing and evaluation of a full day course with the content of instructional design for subject matter experts in the biopharmaceutical industry.

The research design is based on a critical case study in Novo Nordisk with subject matter experts taking part in the development, testing and evaluation of the course.

The findings of the analysis fall into two categories of challenges and one highlighted opportunity. The main challenges to align the documentation of and possession of employee competences in the organisation were the lack of management support in employee learning activities. This resulted in distortions of the role and responsibility of course instructors, which led to minimal transfer possibility of employee learning transfer to behavioural change. The opportunity that study presents for aligning the documentation of and possession of employee competences is to account for management attitude and action towards employee learning process as an important factor in ensuring knowledge and competency transfer for employees.