Pharmaceutical Inspector - GCP

Would you like to be part of work to ensure safe and effective medicines? Can you set direction in a complex and regulated field? Do you have prior experience with ICH GCP and perhaps in addition bioequivalence, clinical trials of medical devices, data management or GLP?

Then you may be the inspector colleague we are seeking in the Medicines Agency's Section for Inspection.

Your primary tasks

Your primary task will be the preparation, conduct and reporting of national and international GCP inspections. In addition, after thorough training and in close cooperation with your colleagues, you will come to work with:

• interpret rules and establish Danish practice
• handle serious breaches
• provide professional input in national and international working groups
• hold meetings with external stakeholders
• answer professional inquiries
• prepare Danish guidelines and international guidelines
• support professional development and knowledge sharing in the team

Your everyday life with us

You will become part of our professional community, which collectively consists of 10 GCP-, GVP-, KAMU-, IT- and GLP-inspectors in Team GCVP. We discuss/ spar about concrete issues and share knowledge across the team. Our core function is to carry out national and international inspections of sponsors and trial sites.

As a GCP medicinal inspector you plan, perform and report inspections in collaboration with the other GCP inspectors in the team. You report to a team leader, but are at the same time part of a responsible and decision-making team.

You must be prepared for long working days during inspections.

Your education, experience and personal qualifications

You have an academic background as a pharmacist, pharmaceutical scientist, engineer, cand.scient. or similar. You have solid experience from the pharmaceutical field and practical experience in quality assurance, quality control or monitoring of clinical trials. Experience with audits or inspections is an advantage.

In addition we emphasize that you

• have good formulation skills, written and spoken, in both Danish and English
• are a team player and value collaboration highly
• are responsible and goal-oriented
• take pride in meeting tight deadlines
• have gravitas and can stand firm when necessary
• maintain an overview in pressured situations
• are diplomatic and have a well-developed sense of situational awareness
• work in a structured way and will contribute to developing and optimizing our workflows
• you enjoy being on the move, as the position will involve a fair amount of travel domestically and abroad

We offer

You will become part of a stable and experienced team, in an informal environment that highly values professionalism.

You will have meaningful and varied work with diverse tasks, where you help ensure that current legislation is followed, and where patient safety is in focus.

You will have great influence on planning your inspections and your other tasks.

We are ambitious and are happy to lead in European and international collaboration in the area. You will have ample opportunity to be involved in many exciting tasks. You will inspect a varied selection of Danish and international trial sites and sponsors. As a medicinal inspector you gain insight into the latest clinical research and can help shape the implementation of new legislation.

The Medicines Agency works systematically to develop itself as a fantastic workplace. This means flexibility and great influence on your own tasks.

About Companies & Control

Company & Control is a unit with just under 100 employees, distributed across sections and teams. We are a mix of pharmacists, chemists, biologists, laboratory technicians and office staff.

The unit is responsible for approval, registration and control of companies that perform tasks with medicines, as well as for the control of companies that perform tasks with medical devices. The unit is also responsible for control of medicines and clinical trials and handles applications for company licenses. The unit participates in the development and implementation of the European Pharmacopoeia, which sets requirements for the technical quality of medicines in Europe.

The unit is also responsible for monitoring illicit handling of medicines, administration of rules on controlled substances and fulfilling the role of the national cannabis bureau. Finally, the unit handles reports of product defects in medicines and assessment of need for possible recalls from the market. Read more about us and our work at Lægemiddelstyrelsen.dk .

About the employment

You will be employed as a special consultant under the applicable agreement between the Ministry of Finance and the Danish Confederation of Professional Associations .

The appointment is covered by the Medicines Agency's guidelines on agreed days off and is therefore not covered by the agency's local flexitime agreement.

At the Medicines Agency we make decisions in authority cases, and it is important to us that our impartiality cannot be questioned. Therefore it is a condition that you do not own shares, parts or interests in a medicines and/or pharmaceutical company. However you have a certain period to sell them if you currently own so-called employee shares in a medicines and/or pharmaceutical company.

Please contact us

Learn more about the position by calling team leader Dorte Fabricius Munksgaard at tel. 23 45 76 34 or medicinal inspector Malene Weis at tel. 45 21 58 60 62. You can read more about us and our tasks at Lægemiddelstyrelsen.dk .

Are you interested?

Click on "apply for the position" and send us your CV and certificate. Instead of an application we would like you to reflect on and answer the following three questions:

• What is important to you in a good working community and how do you contribute yourself?
• What in the job description speaks to you particularly?
• In which situations or contexts are you most challenged?

We continuously invite to interviews around weeks 48 and 49.