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Qualifications

Purpose of consultancy

To contribute to the development and the implementation of harmonized technical requirements, promoting convergence and work-sharing and contributing to accelerate access to essential quality assured medical products by contributing to the development and implementation of facilitated registration pathways based on reliance and collaborative mechanisms including joint activities – dossier assessments and inspections. 

Background  

The functions to be undertaken are critical and are the continuation of initiated projects within the RCN Team, hence it essential that we initiate a new consultancy contract to ensure that this work can be carried on and delivered in a timely manner as these services are of utmost importance to the good functioning of the RCN Team.  The work contributes to the strategic goal of WHO to strengthen regulatory capacity of Member States with respect to medical products.

Deliverables

Objective 1: To provide technical guidance to Member States and Regional Regulatory Harmonization Initiatives and Regulatory Networks in regulatory matters related to medical products upon requests by the respective Member States or Regulatory Harmonization  initiatives/Networks and in accordance with the REG/RCN annual workplan. 

• Deliverable 1.1: Development and revision of Regional Economic Communities (RECs) Medicine Regulatory Harmonization (MRH) programmes harmonized technical guidelines/standards in collaboration with the Health Product Policy and Standards (HPS) Department.

Objective 2: To promote regulatory cooperation, convergence, harmonization and work-sharing in medical products through the provision of technical expertise in the development and implementation of harmonized technical requirements and guidelines involving international and regional regulatory networks and initiatives.  

• Deliverable 2.1: Organization of the International Conference of Drug Regulatory Authorities in 2023 in face-to-face format subject to the improvement of the global edpidemiogical situation related with COVID19 pandemic and related travel restrictions in collaboration with RCN responsible staff members.

Objective 3: To contribute to the establishment and maintenance of electronic platforms to facilitate the authorization of clinical trials and/or medical products in member states. To support the WHO Team in management of WHO-facilitated multi-country joint review procedures for authorization of clinical trials and/or medical products. To develop e-learning training modules for regulatory capacity building in general and to facilitate the implementation of reliance-based mechanisms for regulation of medical products.

• Deliverable 3.1: Development and maintenance of electronic platforms and e-learning training modules to facilitate authorization of clinical trials and medical products.
• Deliverable 3.2: Support WHO-facilitated joint reviews of applications for authorization of clinical trials and marketing authorization.  
• Deliverable 3.3: Develop e-learning training modules to improve regulatory capacity and for implementation of reliance-based mechanisms for regulation of medical products in Member States throughout the whole product life cycle.

Objective 4:National Regulatory Authority Benchmarking.

• Deliverable 4.1: Participate in face-to-face National Regulatory Authority (NRA) benchmarking workshops in selected countries as well as in the Regional Regulatory Harmonization Initiatives as part of the WHO regulatory systems strengthening programme.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree in pharmacy, medicine, biology, biochemistry, microbiology or related sciences.

Experience

Essential:

• 5 to 10 years of relevant experience in regulation, production and/or development of medical products at national and/or international level.
• Experience with national decision making and in advisory and advocacy roles to senior government officials and policy makers.

Skills/Knowledge:

Essential:

• An excellent understanding of the concepts of medical product regulation throughout the product life cycle (including regulation of clinical trials) and of WHO’s policies and strategies in this area.  
• A good knowledge of product development and production as well as issues related to regulation of and access to medical products, especially in the context of low-and middle-income countries.  
• Ability to function effectively in and liaise with multi-sectoral stakeholders with high level of tact and diplomacy. 
• Excellent interpersonal, negotiating and communication skills including presentation skills.  
• Substantial knowledge of all aspects of project management and development.

Languages required:

Essential:  

• Expert knowledge of English.

Location 

Off-site – Home based. 

Travel 

The consultant is 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: 

11 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: 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.
• 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: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html