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  • Anywhere

World Health Organization (WHO)

Consultant – Regulatory policy harmonization and advocacy

( 2210254 )

Contractual Arrangement : External consultant

Contract Duration (Years, Months, Days) : 6 months

Job Posting: Nov 9, 2022, 7:59:09 AM

Purpose of consultancy

To contribute to WHO’s regulatory actions and responses, covering preparatory and implementation phases, for Covid pandemic, Monkeypox outbreak and other public health emergencies of international concern.

Background

The Department of Regulation and Prequalification (RPQ) works with the Access to Medicines and Health Products MHP) Division, aiming to improve efficacy and efficiency of regulatory systems in low- and middle-income countries and to facilitate access to quality-assured, safe and effective essential medicines, vaccines and other health technologies.

The RPQ department has three large areas of work: Prequalification, Local Production and Assistance, Regulation and Safety, working with a wide spectrum of internal and external stakeholders. The work in the Office of the Director (OOD) is based on the WHO General Programme of Work (GPW13) as well as strategic directions provided in the Roadmap for Access to Medicines, Vaccines and other Health Products (2019-2023) and WHO’s five-year plan to help build effective and efficient regulatory systems ‘Delivering Quality-Assured Medical Products for all 2019-2023’.

Since the Covid pandemic in March 2020, RPQ has given its efforts and emphasis on regulatory policy harmonization work with COVAX Regulatory Advisory Group (RAG) which is co-chaired by the RPQ Director and Regulatory Lead at CEPI and also with International Coalition of Medicines Regulatory Authorities (ICMRA) and other key regulatory agencies.

Continued efforts in the area is critical in managing and preparing for efficient and effective harmonized regulatory systems to ensure access to quality-assured, safe and effective vaccines, diagnostics and treatments for health emergencies. This effort will be extended to ensure coordinated actions for three levels of the organization.

RPQ will also ensure to advocate its work not only to regulatory communities, but also to donors, academic/scientific communities, civil societies, Member States and more to promote further harmonization and importance of efficient and effective regulatory systems in Universal Health.

Deliverables

  • Deliverable 1: Verbal and written communications / briefings on unexpected emergency issues with an open communication line without time restrictions. Such briefings will include key highlights from WHO Acute Events Management (AEM) daily meetings. Summary report to be prepared once every two months.
  • Deliverable 2: Monthly WHO information report, focused on regulatory updates, to the International Coalition of Medicines Regulatory Authorities (ICMRA) and other stakeholders, expected at the end of each month.
  • Deliverable 3: Preparation and follow-up actions from COVAX Regulatory Advisory Group (RAG) weekly meetings, including bi-weekly RAG Co-chairs preparatory meetings. Summary report to be prepared once every two months.
  • Deliverable 4: Preparation and recap and follow-up of actions from bi-monthly ICMRA Policy meetings. Summary report to be prepared once every two months.
  • Deliverable 5: Preparation and recap of key highlights from ICMRA working group meetings. Summary report to be prepared once every two months.
  • Deliverable 6: Recap of key highlights from WHO Strategic Advisory Group of Experts (SAGE) meetings, including SAGE Covid-19 working group meetings. Summary report to be prepared once every two months.
  • Deliverable 7: Contributing to the preparation of WHO R&D Blueprint workshops, followed by preparation of brief recap and key highlights from each workshop to be provided within one week of the end of each workshop.
  • Deliverable 8: Contribute to the RPQ Impact Assessment and its interim reporting to the RPQ donors in February 2023. Report submitted by 28 February 2023.
  • Deliverable 9: Open-reporting on key regulatory-related items from science-focused meetings. Summary highlights to be prepared once every two months.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

  • Advanced degree in medicine, biology, pharmacy or public health.

Desirable:

  • A Ph.D in medicine, biology or pharmacology.
  • Specialized training in regulatory science.

Experience

Essential:

  • 5 to 10 years of relevant experience in regulatory science, management of communicable and noncommunicable diseases, including access to medicines and health products for low- and middle-income countries.
  • At least 5 years international experience.
  • Experience in project management with emphasis on integrated coordination and policy implementation with internal and external stakeholders.
  • Experience in working with international regulator networks.

Desirable:

  • Experience in planning and coordination of multidisciplinary public health programmes, which may include the implementation of a public health/disease control programme.

Skills/Knowledge:

  • Expert level knowledge of WHO policies and processes in access to medicines and health products, regulation and public health, regulatory harmonization tools, systems and networks, prequalification programmes and pharmacovigilance.
  • Knowledge of immunization policy recommendations issued by WHO Scientific Advisory Group of Experts as well as work of R&D Blueprint on emerging infectious diseases.
  • Excellent analytical skills.
  • Ability in managing diverse subject areas which require agility, flexibility, coordination and positive spirit.

Languages required:

Essential:

  • Expert knowledge of English.

Desirable:

  • Intermediate knowledge of French.

Location

Home based – Off-site.

Travel

The consultant is not expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B-USD 7,000

9,980 per month.

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

N/A

Expected duration of contract:

6 months.

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: (link) Some professional certificates may not appear in the WHED and will require individual review.
  • For information on WHO’s operations please visit: (link)
  • 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 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: (link)-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html
Tags: covax, covid, essential medicines, health emergencies, health programmes, immunization, impact assessment, infectious diseases, noncommunicable diseases, pharmacy, project management, regulatory agencies, social security contributions