TECHNICAL OFFICER (HQ/14/HIS/FT323)

25 May 2016
 
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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/14/HIS/FT323
 
Title: Technical Officer
 
Grade: P5
 
Contract type: Fixed-term Appointment
 
Duration of contract:  one year renewable, subject to satisfactory performance and continuing need for the post
 
Date: 8 July 2014
 
Application Deadline: 18 July 2014 Vacancy Filled
 
Duty Station:  Geneva, Switzerland
 
Organization unit: HQ/HIS Health Systems and Innovation (HQ/HIS) /
HQ/EMP- Essential Medicines and Health Products (HQ/EMP)
HQ/PQT Prequalification Team
 
OBJECTIVES OF THE PROGRAMME :
The Prequalification Team's (PQT) objective is to adopt actions in collaboration with product developers, manufacturers and regulatory bodies, so that health products are evaluated effectively and efficiently, made available to health care providers and populations with minimum delay and subject to qualified laboratory control. To achieve this objective PQT has an important function in focusing on the systematic development of the technical capacity of manufacturers, regulators and testing laboratories in regions and countries, which are of strategic importance to PQT. PQT deals with the improvement of the quality of data submitted to the Team, the improvement of the level of Good Clinical Practice (GCP) compliance for manufacturers applying to PQT, and improvement of essential regulatory and quality control functions in producing countries. The Team aims to improve the knowledge of regulatory staff in less developed countries where prequalified health products are supplied in order that these countries are able to better regulate prequalified health products used by their public.
Description of duties:
Under the overall supervision of the Coordinator of PQT, the responsibilities of the Group Leader are:
1. Prequalification of health products for priority diseases:
a. Design and implement strategies to coordinate the provision of technical assistances, laboratory services and capacity building within PQT.
b. Plan and coordinate technical assistances to those manufacturers and testing laboratories who have the potential to contribute to PQT's objectives, in order to support them in achieving required technical maturity. To communicate with manufacturers and testing laboratories by providing information about PQT and its technical requirements. To organize joint trainings with regulators, if feasible.
c. Plan and coordinate laboratory service to support the prequalification functions, including selection of laboratories competent for expected testing, coordination of quality control projects and laboratory testing, interpretation and communication of laboratory results.
d. In cooperation with WHO Regional and Country Offices, assist governments in developing countries in the organization of projects enabling manufacturers, testing laboratories and national regulatory authorities to participate actively in the prequalification agenda.
e. Propose, manage and coordinate programmes in support of the adoption of WHO and other harmonized international technical standards for medicines, in cooperation with teams across the Department, other WHO units and offices and UN organizations.
f. Technical leader for the organization of prequalification related capacity building activities, ensuring that prequalification programmatic activities and trainings are adapted to current needs. Organize follow-up activities to monitor the impact of capacity building interventions.
g. Provide technical and managerial direction to WHO Regional and Country Offices on the acceleration of regulatory approvals and capacity building, assuming the role of focal point for the programme formulation, implementation and delivery.
h. Assist Member States in the development of sustainable regulatory policies and workable practices in the acceleration of regulatory approvals of priority medicines and other health products.
i. Advocate and liaise with governmental authorities, the UN system and other PQT collaborators, including regulatory authorities in low-, middle-income and industrialized countries (ICH (International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use) and associated countries) for the enhanced coordination and innovative delivery modalities that secure the acceleration of regulatory approvals and competent quality monitoring in support of PQT objectives. Identify and promote opportunities for collaborative capacity building programmes aimed at improving the quality of health products. For this purpose, develop and maintain relationships with the main international regulatory bodies and professional organizations.
j. To contribute to the reviewing, updating and establishing of prequalification requirements, guidelines, procedures and related quality systems for assuring the quality, safety and efficacy of priority health products, based on existing relevant WHO norms, standards and guidelines, and other existing regulatory guidance documents, as appropriate.
k. Manage projects within the area of responsibility and participate in financial planning and fundraising.
2. Operational Procedures and related documentation:
a. To manage, within PQT, the quality system regarding the agenda of technical assistances, laboratory services, collaborative registrations and capacity building, including drafting and maintaining standard operation procedures (SOPs).
b. To assist, as necessary, in liaising with other staff members in the Essential Medicines and Health Products department (EMP), in the development, implementation and review of SOPs and guidelines related to the prequalification agenda and EMP normative activities.
c. Use available managerial tools for monitoring, evaluating and reporting.
3. Related activities:
a. To cooperate with other professional and general staff within the Department in activities related to the quality, safety and efficacy of health products.
REQUIRED QUALIFICATIONS
Education:
Essential: University degree in pharmacy or medicine with an advanced university degree (Masters level or above) in the pharmaceutical, pharmacological or laboratory testing area.
Skills:
Extensive knowledge of regulation of health products, with relevance to their quality, safety and efficacy and laboratory control procedures applied by Stringent Regulatory Authorities such as in the European Union. Extensive knowledge of WHO prequalification and applicable procedures. Good overall knowledge of international trends and developments in health products' regulation and quality control. Excellent knowledge of medicines policies and of the essential medicines concept. Good overall knowledge of regulatory data requirements, GCP (Good Clinical Practice) requirements, quality control requirements, quality monitoring and pharmacovigilance. Good communication skills and ability for team work with capacity to operate in an international and challenging environment. Ability to exercise sound professional judgment.
The incumbent is expected to have a knowledge of general office software applications for word processing and basic database management.

WHO Competencies:
1. Creating an empowering and motivating environment,
2. Communicating in a credible and effective way,
3. Building and promoting partnerships across the Organization and beyond,
4. Fostering integration and teamwork, and
5. Ensuring the effective use of resources.
Experience:
Essential: At least 10 years' of relevant experience in a national regulatory authority at a senior level (head of agency or head of key technical department in the agency). Regional and/or international experience in the management of product quality issues, harmonization of regulatory affairs and collaboration between different national regulatory agencies and testing laboratories. Experience in working with stakeholders involved in development, production and regulation of health products, such as manufacturer's associations, governmental and academic institutions, international development agencies and foundations. Well established writing and drafting skills in the area of regulatory affairs.
Desirable: Experience in working with health products' manufacturers and regulatory authorities in low- and middle-income countries. Work experience in writing project proposals and successful fundraising. Experience in university teaching and adult education.
Languages:
Essential: Expert knowledge of English.
Desirable: Beginners knowledge of French.
Additional Information:
Other similar positions at the same grade level may be filled from this vacancy notice.

This vacancy is published in English only.
Annual salary: (Net of tax)
US$80,887 at single rate
US$87,069 with primary dependants
Post Adjustment: 105.5 % 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.

Vacancy Filled

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