Roster of Consultants – In Vitro Diagnostics Assessment

Purpose of consultancy

To provide technical guidance to the In Vitro Diagnostics Assessment Team with the following:

• product dossier component of the WHO Emergency Use Listing procedure;
• product dossier component of the prequalification (PQ) assessment;
• review of submissions and report preparation for the In Vitro Diagnostic Expert Review Panel assessments; and
• the development and finalisation of the Prequalification of Diagnostics Technical Specifications Series, Prequalification of Diagnostics Technical Guidance Series for The World Health Organization Prequalification of Diagnostics.

Background

The World Health Organization Prequalification of In Vitro Diagnostics is a comprehensive quality assessment of individual In Vitro Diagnostics through a standardized procedure aimed at determining whether the product meets the World Health Organization prequalification requirements. The Prequalification Unit maintains a roster of consultants that assist the In Vitro Diagnostics Assessment team with various tasks related to the product dossier component of the prequalification assessment. Consultants must have a clear understanding of regulatory requirements related to the dossier review, including the respective standards and internationally accepted guidance documents, the major regulatory harmonization initiatives and the respective guidance. The consultant should have experience with dossier screening and dossier-related guidance and specifications development.

The In Vitro Diagnostics Assessment Team is in need of consultants with a comprehensive knowledge of In Vitro Diagnostics and the challenges related to their use in resource-limited settings. A critical component of the assessment process relates to a technical review of the product dossier. To undertake this activity, external consultants, with proven technical expertise, are utilised to conduct the product dossier review. As the World Health Organization continues to expand the disease areas for prequalification assessment, Technical Specifications Series documents are required to be developed to outline the minimum performance criteria to be submitted as part of the product dossier to meet prequalification requirements for new manufacturers. Subject matter consultants with proven technical expertise, are utilised to draft Technical Specification Series documents for new or existing disease areas for public consultation, and to also assist in the expert review of public comments in the finalization of the Technical Specification Series publications.

The World Health Organization Prequalification of In Vitro Diagnostics also undertakes Emergency Use Listing assessment of commercially available In Vitro Diagnostics with emphasis on point-of-care nucleic-acid tests and antigen rapid diagnostic tests and their suitability for use in resource-limited settings. As the SARS-CoV-2 pandemic evolves, in this rapidly changing environment, WHO requires consultants who keep abreast of the current state of knowledge relating to COVID-19, diagnostics, and quality issues as they become known in the public space, with a particular emphasis on use in resource limited settings, reflecting the needs of some WHO Member States.

In addition, the In Vitro Diagnostics Assessment Team coordinates an Expert Review Panel mechanism to review the risks and benefits associated with procurement and use of In Vitro Diagnostics that may have a high public health impact, but that are neither prequalified nor have yet undergone stringent regulatory assessment by a founding member of the Global Harmonization Task Force (now the International Medical Device Regulators Forum).

Deliverables

• Deliverable 1.1: Conduct assessments of product dossiers and related material for In Vitro Diagnostics submitted for prequalification.
• Deliverable 1.2: Contribute to the development and finalisation of the PQDx Technical Specifications Series, Prequalification of Diagnostic Technical Guidance Series for prequalification.
  Expected by: To be completed before end of contract. However, the output will be based on materials whose arrival is not able to be predicted. Dossier review reports, corrective action review reports and/or commitment review reports will be completed within the pre-defined timeframe.
• Deliverable 2: Review dossiers and related materials, including corrective action plans, commitments and change requests, submitted for Emergency Use Listing assessment. Draft documentation (reports, letters, etc) arising from Prequalification of In Vitro Diagnostic dossiers reviews, dossier corrective action plans, commitments and change requests.
  Expected by: To be completed before end of contract. However, the output will be based on materials whose arrival is not able to be predicted. Dossier review reports, corrective action review reports and/or commitment review reports. Reports will be completed within the pre-defined timeframe.
• Deliverable 3: Review manufacturer submissions to a new round of the Expert Review Panel for Diagnostics, contribute to the risk-benefit assessment and provide a completed expert review panel report.
  Expected by: To be completed before end of contract. However, the output will be based on materials whose arrival is not able to be predicted. Review of manufacturer submissions and finalization of expert review panel reports will be completed within the pre-defined timeframe.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

Advanced University Degree in Health Sciences or related medical/scientific field

Desirable:

PhD degree in a related scientific field

Experience

Essential:

Over 10 years’ experience working in research, development and manufacturing of in vitro diagnostic medical devices and/or implementation of diagnostic testing for public health.

Desirable:

• Working experience in different geographical regions, including resource-limited settings.
• Experience in development of target product profiles for diagnostic tests
• Experience in implementation of diagnostic testing in resource-limited settings
• Experience in assay development and/or evaluation

Skills/Knowledge:

• Knowledge of In Vitro Diagnostic manufacturing processes
• Knowledge of WHO Technical specification guidance

Languages required:

Essential:

Expert knowledge of English

Location

Home based – Off-site.

Travel

No travel is expected

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C - USD 500 - 625 per day.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract (Maximum contract duration is 11 months):

Maximum contract duration is 11 months. Additional 11 months contract may be offered based on satisfactory performance.
Consultants will be working not more than 12 days per month.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for 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 will require individual review.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html

For roster VNs:

The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.