Technical Officer (Standards and Norms)
|Closing Date : 2017-01-18|
Duty Station : Geneva, Switzerland
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The mission of WHO is the attainment by all peoples of the highest possible level of health.
Vacancy Notice No:HQ/16/RHT/TA324
Title: Technical Officer (Standards and Norms)
Contract type: Temporary appointment
Duration of contract: 12 months
Date:28 December 2016
Application Deadline:18 January 2017
(20 day(s) until closing deadline)
Currently accepting applications
Duty Station:Geneva, Switzerland
Organization unit:HQ/RHT Regulation of Medicines and other Health Technologies (HQ/RHT) /
HQ/TSN Technologies Standards and Norms (HQ/TSN)
OBJECTIVES OF THE PROGRAMME :
The Department of Essential Medicines and Health Products (EMP) works with Member states and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The EMP department works with the HIS cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS,
TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Millennium Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.
The department has three large areas of work: (1) Regulation of Medicines and other Health Technologies (RHT) unit (covering medicines, vaccines, other biologicals, blood products, medical devices and diagnostics), which consists of four teams covering the normative and standard setting work, the prequalification of medicines, vaccines and diagnostics for UN and international procurement, the strengthening of regulatory systems and networks, and the safety and vigilance of health technologies. RHT is also responsible for work on detection and prevention of substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products. (2) Policy, Access and Use team, which includes the Expert Committee of Selection and Use of Essential medicines, and the Expert Committee on Drug dependence, and covers the work on national
policies, procurement, supply management and pricing of health technologies. (3) Public Health, Innovation and Intellectual Property team which covers the Global Strategy and Plan of Action on Public health, Innovation and Intellectual property, and works with countries on local production and transfer of technology approaches; and on strategies for management of intellectual property issues. This position is with the Technologies Standards and Norms Team (TSN).
The incumbent of this short-term position wil lprovide guidance and report to the Group Lead, Medicines Quality Assurance, in the preparation of the working documents for the WHO Expert Committee on Specifications for Pharmaceutical Preparations leading to new WHO guidance and standards especially serving the National Regulatory Authorities (NRA).
Description of duties:
Purpose of the Position:
The purpose of this short term position is to strengthen the regulatory capacity of the medicines quality assurance group and to provide technical expertise and guidance into the development and maintenance, guidelines and good practices of special importance for the area of quality assurance and bioequivalence.
Under the overall supervision of the Group Lead, Medicines Quality Assurance within TSN, the incumbent will independently and in a timely manner carry out the following tasks:
1. Coordinate the relative information towards the development of new WHO medicines quality assurance guidelines in the areas of development, production, distribution, inspection, quality control and other regulatory guidelines following the recommendations of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).
2. Provide expertise and develop new guidance for implementation by regional and national authorities in the area of Medicines and Quality Assurance to ensure the interchangeability of generic medicines.
3. Undertake research for scientific working documents serving the preparation of new guidance policies and strategies in medicines quality assurance and related regulatory aspects following international trends and new science in collaboration with the WHO Expert Advisory Panel.
4. Oversees the coordination of WHO CCs linked to the development of regulatory guidance for generic medicines to ensure their interchangeability.
5. Coordinate with National and Regional Regulatory Authorities the entries for pharmaceutical products in WHO's International Comparator Products and Biowaiver Lists through the International Generic Drug Regulators Pilot.
6. Manages the timely reporting of WHO Medicines quality assurance initiatives to ensure adequate response to the ECSPP recommendations and build partnerships with national and regional regulatory authorities.
7. Perform all other related duties as assigned.
An advanced university degree (Masters level or above) in Pharmaceutical Sciences, or natural sciences or related field.
PhD in Pharmaceutical Sciences or natural sciences.
In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU) / United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/ . Some professional certificates may not appear in the WHED and these will be reviewed individually.
Comprehensive knowledge of medicines regulation with a special emphasis on the procedures and processes involved in the regulatory steps and actions of the national medicines regulatory authorities. Good knowledge of WHO quality and regulatory standards for pharmaceutical products and international regulatory requirements for marketing authorization of medicinal products, including for interchangeability of multisource (generic) products. Good professional drafting and communication skills. Good networking skills. Ability to work under time pressures. Working knowledge of the Microsoft suite of programmes. Experience with regulatory databases.
*1. Fostering integration and teamwork
*2. Respecting and promoting individual and cultural differences
*3. Producing results
4. Communicating in a credible and effective way
At least seven years of working experience, including in a national regulatory agency or related professional experience with in-depth knowledge and hands-on experience of dealing with the pharmaceutical aspects of marketing authorizations. Experience in the administration and management of national regulatory authorities (NRA) related tasks, such as case management. Experience in working together with other agencies and experts in an international regulatory environment.
Experience in representing a NRA in international meetings and fora.
Expert knowledge of English.
Beginners knowledge of French.
This vacancy is published in English only.
Please visit the following websites for detailed information on working with WHO:
http://www.who.int (to learn more about WHO's operations)
http://icsc.un.org Click on: Quick Links > Salary Scales > by date
WHOs salaries are calculated in US dollars. They consist of a base salary and a post adjustment, which reflects the cost of living in a particular duty station and exchange rates. Other benefits include: 30 days annual leave, family allowance, home travel, education grant for dependent children, pension plan and medical insurance.
WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
Applications from qualified WHO staff from other duty stations are encouraged, as long as they have completed half of their standard duration of assignment (SDA) and have been in their current position for at least two years.
Annual salary:(Net of tax)
US$69032 at single rate
US$74130 with primary dependants
Post Adjustment:80 % of the above figure(s). This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation.
This vacancy notice may be used to fill other similar positions at the same grade level.
A written test and interviews may be used as a form of screening
Online applications are strongly encouraged to enable WHO to store your profile in a permanent database. Please visit WHO's e-Recruitment website at: www.who.int/employment. The system provides instructions for online application procedures.
All applicants are encouraged to apply online as soon as possible after the vacancy has been posted and well before the deadline stated in the vacancy announcement.
WHO is committed to workforce diversity.
Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual. Only candidates under serious consideration will be contacted.
Currently accepting applications
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