National consultant to provide technical assistance on strengthening the National Regulatory Authority

Call for Expressions of Interest and Proposal

# 048 – Job title: National consultant to provide technical assistance on strengthening the National Regulatory Authority, including regulatory preparedness for COVID-19 vaccines, under the World Health Organization Representative Office in Viet Nam.

1. Background

The COVID-19 pandemic has emerged as a global public health crisis and hundreds of research groups are engaged in developing vaccine candidates to protect people. With more than four million deaths, more than two hundred million infected by COVID-19 worldwide, and challenges to accessing COVID-19 Vaccines equitably, it is important to note that international cooperation is most urgently needed to overcome this. Viet Nam WHO country office has supported the National Regulatory Authorities (NRAs) Vietnam to ensure the quality, safety, and efficacy of COVID-19 Vaccines as well as to enhance access to COVID-19 Vaccines in Viet Nam. Viet Nam’s national regulatory authority (NRA) for a vaccine has enhanced its capacity in recent years and has recently achieved the Maturity Level 3, the second highest in the WHO classification of the national regulatory system. However, COVID-19 vaccine research, development and marketing authorization are still challenging tasks. The Ministry of Health has requested WHO to support the capacity building of Viet Nam’s NRA in this area, which includes technical support and experience sharing from international experts and relevant countries.

2. Objective

To provide technical assistance on strengthening the National Regulatory Authority, including regulatory preparedness for COVID-19 vaccines, under the World Health Organization Representative Office in Viet Nam.

3. Work to be performed

Method(s) to carry out the activity

Under the direct supervision of the UHC Team Coordinator and close work with a Go WHO Fellow in charge of essential medicines and NRA strengthening, Vaccine Preventable Diseases and Immunization (VDI) officers and communication officers as a team, the incumbent will carry out given activities. Specific responsibilities include, but are not limited to, the following:

• Assist in coordination and preparation of activities to strengthen COVID- 19 vaccine regulation

• Liaise closely between participants and counterparts such as DAV, ASTT, and NICVB.

• Review and translate Vietnamese technical documents to the English version and vice versa.

• Ensure that activities are performed in an effective and timely way, to a high professional standard, and in line with WHO policies and procedures.

• Perform other related duties as needed.

Output/s

Technical support to strengthen COVID-19 vaccine regulation, including emergency use authorization, import permit, research and development on evaluation of COVID-19 vaccines, and vaccine technology transfer

Deliverable/s

Deliverable 1.1: Concept notes, meeting minutes, and summary reports of online sessions and other meetings

Deliverable 1.2: Archived technical documents including English and/or Vietnamese versions such as import permit, emergency use authorization, research and development on evaluation of COVID-19 vaccines, and related government regulations and international guidelines.

4. Specific requirements

Qualifications required:

Education:

o Essential: A university degree in relevant area including pharmacy or medicine from a recognised university.

o Desirable: A post-graduate degree in relevant area including public health or pharmacy from a recognised university. Experience:

o Essential: A minimum of two years of experience in medicines, medicines regulations and health care systems in national, regional and international organizations. Demonstrated exposure at the international level.

o Desirables: Relevant work experience in WHO or the UN system would be an asset.

c. Skills / Technical skills and knowledge:

o Strong analytical, planning and operational skills

o Knowledge and skills in literature review and searching technical publications

o Proven ability to synthesize complex information to show good judgement and to generate approaches

o Excellent written communication skills, including proven ability to write clear and concise documents, including reports, submissions and briefing documents

o Proficiency with MS Office Suite, with excellent MS Word, Excel and PowerPoint skills

d. Language requirements:

o Essential: Expert knowledge of both English and Vietnamese

e. WHO Competencies

o Teamwork

o Respecting and promoting individual and cultural differences

o Communication

o Producing results

o Knowing and managing yourself

5. Place of assignment

o The consultant is expected to perform her/his work at WHO Viet Nam, Country Office in Hanoi, Viet Nam

6. Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

7. Travel: NA

8. Budget: Please take note of the following when submitting application:

- The contractor will be responsible for paying taxes, if any.

Those who are interested can contact our focal person with contact detail at the end of the announcement before/by 08 Sept 2021 and should be addressed to:

Administrative Office

World Health Organization

UN Building, 304 Kim Ma Street,

Hanoi, Viet Nam

wpvnmapplicants@who.int

For further information on this TOR, please contact: wpvnmwr@who.int