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Qualifications

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Purpose of consultancy

The purpose of the Roster of Experts (ROE) is to provide trusted technical, scientific, regulatory, leadership, and management support to the AVAREF Secretariat, which will, in turn, support the development of comprehensive regulations for clinical trials, procedures for review of Clinical Trials Applications and dossiers for registration of vaccines, bio-therapeutics, pharmaceutical drugs, bio-similar and generic drugs as well as post-marketing surveillance activities.

Background  

African Vaccine Regulatory Forum (AVAREF), established in 2006, is a platform for building ethics and regulatory capacity for clinical trials in Africa and promoting the harmonization of standards, norms and/or processes for oversight for ethics and regulations for clinical trials on the continent. AVAREF is a network of African National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) from 55 African countries that use harmonization and reliance as pillars for capacity building. 

AVAREF uses harmonization and reliance as pillars for capacity building, ensuring that there is collaboration between national ECs and NRAs in countries as well as across countries by promoting activities such as joint reviews, training, provision of guidelines and other tools, work-sharing and use of expertise of all involved, including key partners. AVAREF intends to deliver on its capacity building initiatives within the new ecosystem by:

1.     Leveraging on its network approach used for excellence in capacity building. This includes delivery of customized capacity building activities to the needs of member states, including those who has managed to increase their maturity levels; and as such require specialized deep training and/or capacity building.

2.   Adopting a life cycle approach for innovation, namely research (basic, applied, and clinical), commercialization, manufacturing, registration (regulation), post registration safety (post-market safety), risk management, and risk communication.

3.     Leveraging on existing and new partnerships to enhance its ability to deliver results.

4.     Leveraging on a pool of experts and linkages with international regulatory authorities to establish and maintain the necessary expertise, skill sets, and experienced human resources required to support NRAs and NECs but also the realization of AMA.

Deliverables

Under the direct supervision of the WHO AVAREF Coordinator, as well as the technical and programmatic guidance of UHC/CN AFRO, the incumbent will plan, develop, and implement programmes and activities for disease prevention and control – including: (i) leadership on coordination, partnerships, and resource mobilization for disease control; (ii) development of WHO disease control technical products, services, and tools; (iii) generation of analytics-driven strategic information for disease control agenda setting and interventions; and (iv) technical support and institutional capacity building support –  culminating in WHO focused investments in support of the following country outcomes: systems and governance capacity building; disease interventions coverage expansion; institutional capacity building; individual, national, and continental human resource capacity building; research and  innovation capacity building; quality of care improvement; and disease-related regulatory systems capacity building.

The expert scientist, medical, or regulatory professional will be expected to provide training, coaching, and / or mentoring to scientific evaluators, managers, or leaders in the NRAs to support ongoing capacity development and maintaining of expertise in the African region. The experts may be paired with local reviewers or experts for the purpose of achieving coaching / mentoring goals. The expert is also expected to lead aspects of the development of various initiatives, programs, policies, frameworks, strategies, and operations aimed at providing regulatory capacity building to member states in these main areas of – other content details are available in the full post description:

1.     Leadership on coordination, partnerships, and resource mobilization for regulatory capacity building in support of ending diseases in Africa

2.     Development of WHO Technical products, services, and tools for Regulatory and Ethics Oversight over medicines research, design, regulation, commercialization, manufacturing, safety, and post-registration safety monitoring 

3.     Generation of analytics-driven strategic information for disease control agenda setting and interventions tailoring 

4.     Technical support and institutional capacity building for ethics and regulatory capacity building for NRAs, NECs, and related organizations

5.     Performing other related responsibilities as assigned, including replacing and backstopping for others as required.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

Advanced University degree (Master’s or higher) in Medicine, Biomedical Sciences, Physical Sciences, or Health Sciences, or in health-related field (medicine or health), Biostatistics.

Desirable: 

Advanced degree in medicine / public health / communicable/non-communicable diseases.

Advanced degrees in Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.

Clinical specialization in Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology.

Experience

Essential:

Experience requirements

Interested candidates are expected to have a minimum of 7 years of experience and possess at least three (3) of the following essential requirements: 

·         Significant experience working in an internationally recognized national regulatory agency (ML-4)

·         Significant experience in performing clinical trials as a principal investigator and capacity building within the sector in low to middle income countries

·         Significant experience in aspects of regulation of medicines including vaccines, biotherapeutics, pharmaceuticals, advanced therapeutics, diagnostics

·         Significant experience in the review of clinical trial dossiers, registration of new and/or or existing medicines

·         Experience in medicines regulatory affairs including submission management, project management, quality management, and regulatory excellence

·         Experience in the development and/or implementation of guidelines, policies, standards or regulations for clinical trials, medicines submissions and/or post-market surveillance

·         Significant experience in regulation of vaccine manufacturing

·         Significant experience in regulation of biotherapeutics, biosimilars, other biologics

·         Significant experience in the regulation of cell, tissue, and gene therapies 

·         Demonstrated experience in medicines review and approval process in an internationally recognized national regulatory agency

·         Demonstrated experience leading and/or managing a team, division, or organization performing any of the above-mentioned functions in science-based organization

Desirable:

Expertise in one of the following areas:

·         Expertise in review of non-clinical and clinical data for vaccines and drug registration dossiers, Good Clinical Practice Inspection (GCP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Post Marketing Surveillance and monitoring, Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.

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          Expertise in clinical specialties such as Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology 

Skills/Knowledge:

Essential:

·         Ability to identify problems, formulate arguments and opinions, formulate conclusions and recommendations.

·         Ability to review and revise policies and objectives of the program and assigned activities.

·         Ability to work under pressure and tight deadlines

·         Excellent knowledge of health and safety regulations and technical aspects of the specialty area.

·         Excellent writing and oral communication skills.

·         Excellent diplomatic and interpersonal skills.

·         Ability to develop innovative approaches and solutions;

    Languages required:

Essential:  

• Expert knowledge of English, or French or Portuguese 

Desirable: 

• Intermediate knowledge of one of the UN official languages. 

Location 

On-site in one of the countries within the WHO African Region or off-site (remote work).

Travel 

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B – USD 8,500 – 9,980 per month.

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

TBD

Expected duration of contract: 

Contract duration will vary depending on the need.

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 each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO. 

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.