Lægemiddelstyrelsen
ONCOLOGIST OR HEMATOLIST FOR THE DANISH MEDICINES AGENCY
Fuldtid
Permanent
Axel Heides Gade 1, 2300 København S, Danmark
ID: 2841777
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Indrykket for 16 dage siden
Are you an oncologist or hematologist or medical doctor with similar qualifications and interested in pharmaceuticals? Are you considering a medical job outside the clinic, or do you have a background in the pharmaceutical industry and want to try something new?
All new medicines that are introduced in the clinic have been given a marketing authorization after a thorough approval process, where data from the clinical trials are carefully reviewed.
If you want to help approve medicines for the benefit of patients and society, come join us at the Danish Medicines Agency, where an exciting position awaits you.
About Us
The Danish Medicines Agency is Denmark's national authority for approval and monitoring of medicines, medical devices and clinical trials. We are approx. 650 employees in the Danish Medicines Agency in Islands Brygge, Copenhagen where we collaborate closely with the other European medicine’s agencies, including the European Medicines Agency EMA (European Medicines Agency). We participate in various professional drug committees and working groups with other European experts.
The position is in the Section for Human Medicine, where we are currently approx. 20 doctors of which 8 are doctors with a hematology or oncology background. We evaluate clinical data in connection with the approval of new drugs and updates to approved drugs, including new indications. Denmark already has primary regulatory responsibility (Rapporteurship) for a large portfolio of cancer medicines (both solid and hematological) where we assess both new extensions of indication as well as many completely new innovative medicines with a view to approval Your closest colleagues will be doctors, pharmacists, toxicologists and statisticians. We work in an interdisciplinary manner, often in small work groups.
Your everyday life with us
Your tasks are to evaluate clinical data for medicines, including oncological and hematological medicines. Does the medicinal product have a clinically relevant effect on the intended patient population? Is there a reasonable balance between efficacy and safety? Is there a particular risk in certain patient populations, e.g. elderly, kidney or liver disease? In addition, you will also make assessments of marketing authorizations for products within other therapy areas, and you will gain broad experience with the regulatory procedures at both the national and European level. Finally, you will be involved in the work around risk assessment in connection with shortage situations, assess dispensing permits for non-marketed medicines and answer medicine-related inquiries from citizens, the press and the ministry/politicians.
Your education, experience and personal qualifications
You are a specialist in oncology or hematology. You may also have relevant, solid experience from other regulatory agencies or the pharmaceutical industry and be without formal specialist medical training.
Your scientific and professional expertise is essential, clinical experience is also necessary.
You must have an interest in and flair for evaluating clinical research.
You must be motivated to work interdisciplinarily in an international environment, where English is the daily working language, which you must master at a high level, both orally and in writing.
In relation to your personal qualifications, you can combine and balance the detail-oriented with the pragmatic. In addition, you have good collaborative skills, as well as the ability to work purposefully, maintain an overview and meet deadlines.
We offer
An internationally oriented workplace with close collaboration partners throughout Europe, including through the European Medicines Agency, EMA.
In the long term, you will be able to participate in working groups nationally and in EMA.
You will gain experience in assessing study design and clinical data, as well as an in-depth knowledge of the requirements the authorities set for the approval of medicinal products.
You will be part of a dynamic professional environment, which is characterized by skilled and thorough colleagues, and you will have the opportunity for continuous training in relevant areas, including further professional training.
We have a flexible work organization, and you can largely plan your everyday life yourself. You will be given challenging and varied tasks, and you will have the opportunity to use and develop your skills within a wide range of tasks.
Our working climate is informal and full of commitment, humor and mutual respect.
About the employment
You will be employed as a Senior Medical Officer in accordance with the current collective agreement between the Ministry of Finance and Yngre Læger.
At the Danish Medicines Agency, we make decisions in official cases, and therefore it is important that our integrity cannot be questioned. Therefore, it is a prerequisite for employment at the Danish Medicines Agency that you do not own patents, shares or the like in a pharmaceutical and/or medical company. If you have shares in a pharmaceutical and/or medico company, they must be disposed of.
Are you interested?
You can get more information about the position by contacting Head of Unit Bibi Scharff on tel. 23 63 74 01 or senior physician Mette Linnert Jensen on tel. 25 26 52 23. You can read more about the Danish Medicines Agency at www.laegemiddelstyrelsen.dk.
About the Danish Medicines Agency
The Danish Medicines Agency is part of the Ministry of Health and the authority for approval and monitoring of medicines, medical equipment and clinical trials as well as administration of the pharmacy structure. Our mission is effective, safe and accessible medicines and medical devices for the benefit of patients and society. We are approx. 650 employees and in collaboration we solve an important task on the basis of Danish and European legislation and with an eye to clients, citizens, companies and business partners. In this connection, we are involved in a number of European and international collaborations and strive to take a leading role on a European level.
Our vision is to be a European top-class agency with meaningful work, high professionalism and development opportunities in balance with good physical framework and a focus on health and employee well-being.