Roster of Consultants – Experts for the African Vaccine Regulations Forum (AVAREF) for Trusted Support at World Health Organization

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.

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:

• Leadership on coordination, partnerships, and resource mobilization for regulatory capacity building in support of ending diseases in Africa
• 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
• Generation of analytics-driven strategic information for disease control agenda setting and interventions tailoring
• Technical support and institutional capacity building for ethics and regulatory capacity building for NRAs, NECs, and related organizations
• Performing other related responsibilities as assigned, including replacing and backstopping for others as required.

Educational Qualifications:
Qualifications, experience, skills and languages
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.
• 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;

Essential:
Languages required:

• Expert knowledge of English, or French or Portuguese

Desirable:

• Intermediate knowledge of one of the UN official languages