STC specialized technical expertise for the NRA and on the domestic production of COVID-19 vaccines

In December 2020, Viet Nam’s National Regulatory Authority (NRA) achieved maturity level 3 for regulating vaccines. The NRA has established an institutional development plan for improving NRA functions across its agencies and every two years the NRA is expected to conduct its self-assessment using the WHO Global Benchmarking Tool. For the past decade, the Viet Nam WHO country office has supported Viet Nam’s NRA to ensure the quality, safety, and efficacy of vaccines, and more recently, COVID-19 vaccines. With the COVID-19 pandemic still ongoing, COVID-19 vaccines are one of the most important tools in COVID-19 prevention and response. Since the COVID-19 outbreak, several institutes in Viet Nam have started to conduct COVID-19 vaccine research and development.

The Ministry of Health has requested WHO to continue to support the capacity building of Viet Nam’s NRA to further progress on its institutional development plan, next assessment using the WHO Global Benchmarking Tool, and regulation of COVID-19 vaccines, including clinical trial design of domestic COVID-19 vaccines, vaccine effectiveness, and adverse events following immunization (AEFI) monitoring.

The short-term consultant would support the country office to provide specialized technical expertise for the NRA as it undergoes the WHO Global Benchmarking Tool assessment and on the domestic production of COVID-19 vaccines.

DELIVERABLES

Output 1: Updated NRA institutional development plan and next assessment using the WHO Global Benchmarking Tool

Deliverable 1.1: Summary report on progress of institutional development plan (30 December 2022)

Deliverable 1.2: Summary report on WHO Global Benchmarking Tool assessment (30 May 2023)

Output 2: COVID-19 vaccine research and development roadmap with focus on clinical trial design and vaccine effectiveness

Deliverable 2.1: Summary report on COVID-19 vaccine domestic production (30 October 2023)

Deliverable 2.2: Summary report on mRNA technology transfer capacity building (15 September 2023)

Note: Due to COVID-19, the work and deliverables are subject to change. The incumbent needs to be flexible to adjust to any unforeseen adjustments that might occur during the implementation.

Qualifications, experience, skills and languages

Qualifications required

- Education:

• Essential: Minimum first University degree in medicine, pharmacy or public health from a recognized university and a postgraduate degree in pharmacy, public health
• Desirable: Degree in in regulatory science

- Experience:

• Essential: A minimum of seven years of experience in medicines, medicines regulations and pharmaceutical systems in national, regional and international organizations. Experience in vaccines and medicines regulations.
• Desirables: Relevant work experience in WHO or the UN system would be an asset and in the field of vaccines and medicines clinical trial, and production.

- Skills / and knowledge:

• Strong analytical, planning and operational skills
• Knowledge and skills in literature review and searching technical publications
• Proven ability to synthesize complex information to show good judgement and to generate approaches
• Excellent written communication skills, including proven ability to write clear and concise documents, including reports, submissions and briefing documents
• Proficiency with MS Office Suite, with excellent MS Word, Excel and PowerPoint skills

- Language requirements:

• Essential: Expert knowledge of English

Technical Supervision

Under the direct supervision of the UHC Team Coordinator, Dr Socorro Escalante at Escalantes@who.int and collaboration of Vaccine Preventable Diseases and Immunization (VDI) officer as a team, the incumbent will carry out the given activities.

Specific responsibilities include, but are not limited to, the following:

• Technical support to the National Regulatory Authority in progressing its institutional development plan
• Coordination and facilitation of support to the NRA in the next assessment using the WHO Global Benchmarking Tool
• Technical support to strengthen COVID-19 vaccine regulation, including COVID-19 vaccine domestic production and clinical trial design
• Coordination of NRA counterparts, such as DAV, ASTT, NIDQC, and NICVB, and partners,
• Assist technical officer in coordinating technical support and capacity building to mRNA technology transfer related activitie
• Perform other related duties as needed.

• 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.