Technical Officer – WHO – Copenhagen, Denmark
Description of Duties
- Coordinates the liaison between WHO and UNICEF in relation to the prequalification of Medical products and other Heatlh Technologies;
- Advises the Group Lead in planning, management and coordination of assessments carried out in the WHO Prequalification Team’s Medicines Assessment group;
- Provides technical assessment and evaluation of submitted dossiers from pharmaceutical manufacturers with respect to quality;
- Liaises and communicates with pharmaceutical manufacturers on dossiers submitted for prequalification;
- Develops, maintains and enhances standard operating procedures, guidelines and related quality assurance systems for PQT;
- Provides expert advice on technical issues related to quality issues of medicine as well as providing technical expertise in relevant meetings and Expert Advisory groups;
- Manages the reception, storage and general organization of the product dossiers of PQT, stored at the UNICEF offices in Copenhagen and make available the dossiers to other assessors and inspectors, for example for the assessment weeks organized by WHO.
- An advanced university level degree (masters level or above) in pharmaceutical sciences, or related field.
- At least seven years of national/international working experience in a national regulatory agency as an assessor of the quality part of the dossier or related professional experience with in depth knowledge and hands-on experience of dealing with the pharmaceutical quality aspects of marketing authorizations.
- Experience in the administration and management of quality management systems.
- Comprehensive knowledge of medicines regulation with special emphasis on the assessment of the quality part of the marketing authorization dossiers.
- In-depth knowledge of WHO quality standards for pharmaceutical products and international regulatory requirements for marketing authorization of medicinal products.
- Knowledge of quality management systems.
- Good professional drafting and communication skills.
- Expertise in working together with other regulatory experts.
- Ability to work under time pressures.
Closing date for applications 18 December 2019 before midnight.