E-DRUG: Open call for Expression of interest on WHO Local Production
Consultancy
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The Local Production & Assistance (LPA) Unit at WHO-HQ, has an open call
for expression of interest for experts who are interested in a
consultancy to assist the LPA Unit in strengthening local production and
technology transfer for improving access to quality-assured essential
medicines and other products.
The LPA Unit is responsible for supporting Member States in strengthening
local production and technology transfer of quality-assured essential
health products to improve access and other WHA resolutions and decisions
related to local production and access to health products.
Work to be performed
The selected consultant will be assisting the LPA Unit in supporting Member
States in promoting sustainable quality local production and technology
transfer of in-vitro diagnostics (IVDs) and medical devices, including
organizing and conducting capacity building and technical assistance
activities related to local production and technology transfer of
quality-assured IVDs and/or medical devices (e.g. ISO 13485) and
specialized technical assistance related to WHO prequalification of IVDs.
- Requirements
Qualifications required
- Advanced level university degree in pharmacy, sciences, life sciences (such as biochemistry, biotechnology, and biomedical engineering) or other health or science-related fields.
- Advanced level university degree in a field related to the development,
manufacture and/or performance evaluation of IVDs would be considered an
asset.
Experience required
A minimum of 7 years of professional experience in the pharmaceutical,
sciences, life sciences or other health or science-related field, which
includes professional experience in the development, manufacture and/or
performance evaluation of in vitro diagnostics.
The following experience is desirable and would be considered an asset:
- Professional experience working for a manufacturer of IVDs and/or in the
IVD and/or medical device manufacturing industry
- Professional experience in the development, manufacture and/or
performance evaluation of medical devices
- Professional experience working in a national regulatory authority for
regulating IVDs and medical devices, i.e. assessing for quality, inspecting
manufacturing facilities and/or conducting performance evaluation tests
- Experience with the WHO Prequalification Programme for IVDs
- Experience in, or in collaboration with, an international organization
- Experience working in LMICs
- Experience in organizing meetings/workshops
Skills/Technical skills and knowledge
- Technical knowledge in the development, manufacture and/or performance
evaluation of IVDs
- Technical knowledge in WHO and other internationally-recognized quality
assurance standards for IVDs and medical devices (e.g. ISO, GMP)
- Excellent writing skills
- Good communication and interpersonal skills with the ability to work in a
multicultural team and maintain effective working relationships with
recognized experts and stakeholders
- Strong methodological and analytical skills with the ability to conduct
research, identify and analyse literature relevant to the programme area
- Good planning and organizational skills with attention to detail and with
the ability to multi-task and work under pressure
- Strong IT skills: Word, Excel, presentation software, databases and web
navigators
The following skills and knowledge would be considered as an asset:
- Technical knowledge in development, manufacture and/or performance
evaluation of medical devices
- Technical knowledge in the regulation of IVDs and/or medical devices
- Technical knowledge of the requirements of the WHO Prequalification
Programme for IVDs
Languages
Expert knowledge of English. Working knowledge of another WHO official
language would be an asset.
We kindly request Medical devices/IVD manufacturing associations to
circulate this Expression of Interest among their members.
If you have any interest in this consultancy, please send your full detailed
curriculum vitae (CV), an introduction letter and date of availability by email to the WHO LPA Unit at
localproduction@who.int
with the Subject 'Expression of Interest in Consultancy' by the 16 December
2021.
Claire Trochez
Consultant
Local Production & Assistance Unit (LPA)
Regulation and Prequalification Department (RPQ)
Access to Medicines and Health Products Division (MHP)
World Health Organization
Geneva, Switzerland
trochezc@who.int