Exhibition | Speeddate | Workshop
500
Utrecht
The Netherlands
Every year, nearly 11.5 million people in the Netherlands use medications prescribed by their doctors. Add to that the number of over-the-counter medicines and there are many more. Every patient must be able to trust that the medicine given is both effective and safe. That, in a nutshell, is what the nearly 500 employees of the Dutch Medicines Evaluation Board (MEB) deal with on a daily basis: we assess whether a drug will receive a marketing authorization and thus be allowed on the market. We also monitor all risks and side effects of a drug after it has been admitted to the market. We do this for the Dutch market, but we also play an important role in deciding on international applications via the European Medicines Agency (EMA).
The MEB is part of the Ministry of Health and handles about 20,000 cases a year. These include administrative changes, but also major cases such as a drug file with a completely new active ingredient.
When a pharmaceutical company wants to market a drug, it submits the results of years of research to the MEB for review. So how do you handle such a dossier of thousands of pages? And more importantly, how do you assess whether these results guarantee that a drug is both effective and safe? MEB assessors and regulatory project leaders give you an insight into their work: assessing a new drug is not a matter of ticking off a checklist. It is a complex balancing of benefits and risks, performed by absolute experts. You will be challenged to think about real-world examples. Do you have what it takes to decide on patient safety?
Managing applications for new medicines, keeping an eye on all regulatory aspects and deadlines, and cooperating with stakeholders at European level. That is what you do as a regulatory project leader (RPL) at the CBG in Utrecht. And it is your ideal job if you have fluent skill in the pharmaceutical language and when you enjoy planning and organizing!
The job:
From entry to completion, the registration application for a drug goes through a complex process . That process consists of multiple steps and several colleagues from different areas of expertise work on it. This begs the question: who is in charge? Well, you are! As project leader you are in charge of several dossiers at the same time and you keep track of all activities and expert groups involved in each dossier. You bring content together, you switch between all the different (EU) colleagues who are working on the dossier and you ensure that everything goes according to plan. You prepare the decisions for Board, you make a substantive contribution during board meetings or European consultations and you maintain in contact with pharmaceutical companies and fellow assessment authorities in the EU.
Employee profile:
Keeping dozens of balls in the air at the same time? No problem for you. You remain calm in stressful situations. You are also decisive, have good administrative skills and work in a planned way.
Furthermore:
-> Master or PhD degree in pharmaceutical or (bio)medical direction;
-> Experience in reading and applying (inter)national legislation and regulations is a plus;
-> Excellent oral and written skills in Dutch and English;
-> Successful experience with working under stress or time pressure, and meeting hard deadlines;
-> Preferably some experience with drug registration.
As an Assessor at the MEB, you have an essential role when it comes to the interests of patients. Together with your colleagues, you ensure a sound position in the Dutch or European registration of medicines and you may participate in international discussions about the effectiveness and safety of medicines. If you wish, you can develop into an absolute expert in your area of expertise.
The job:
As a team you will evaluate the clinical part of a registration dossier. This file consists of data on research with healthy volunteers and with patients, and relates to a Dutch and/or a European registration application. You base yourself on the available data, whereby your up-to-date scientific knowledge ensures that you can provide a critical assessment. You will then document your findings in a thorough assessment report. You make recommendations to the Board and to the EMA (CHMP), you provide team-based scientific advice to the pharmaceutical industry in relation to a (future) registration and you will act as an expert at meetings of the Board and the EMA.
Employee profile:
-> background as a physician, pharmacist or scientist with expertise in an indication area such as for example gastroenterology, pulmonary diseases, neurology or infectious diseases;
-> several years of clinical experience;
-> knowledge of statistics and methodology;
-> excellent communication skills, both oral and written in the English language, preferably also in Dutch or willing to learn this at short notice;
Competencies associated with the position: analytical ability, judgment, persuasiveness, initiative, planning & organizing, cooperation & networking, flexibility.
As an Assessor at the MEB, you can participate in discussions about the effectiveness and safety of medicines at national and European level. You are in direct contact with the Board members who decide and who need your opinion.
The biggest challenge is to get a clear picture of the efficacy and safety of a drug within the set time frame. If you want, you can develop into an absolute expert in a certain indication area.
The job:
As Quality Assessor you are responsible for assessing Module 3 of the registration dossier for national and European admission of human medicines. Module 3 defines how the drug is produced and how the quality of the drug is guaranteed. You assess whether the production procedure and controls described by the manufacturer sufficiently guarantee that the drug meets international quality requirements. You record your findings in an assessment report and, where necessary, you present that report in national and international meetings. You are also involved in scientific advice to producers during the development of new drugs.
Employee profile:
You have a critical mind, good analytical skills and persuasiveness. You can also cooperate well, as there is intensive contact with your colleagues. You can deal with strict deadlines and you do not easily get stressed. In addition, you are strong in frequently switching between different tasks and activities.
Furthermore:
-> education as (bio)pharmacist, (medical) biologist, pharmacist or similar;
-> several years of work experience within the (bio)pharmaceutical industry, university or completed PhD research;
-> experience with relevant (biological/biotechnological/biopharmaceutical) development work or research;
-> excellent communication skills in Dutch and English, both oral and written.
If you are interested in working with us or learning more about the MEB, please do not hesitate to contact us:
werving@cbg-meb.nl
We will be happy to answer your questions and share with you why we are proud to work at MEB!