Consultant – Paediatric medicines innovation and access

Innovation

Overview

Provide technical expertise and support for paediatric medicines initiatives.

You have:

• University Degree in medical or social sciences.
• Postgraduate degree in clinical epidemiology, public health or equivalent preferred.
• At least 5 years of relevant experience in managing and coordinating collaborative projects.
• Experience with clinical research (i.e., PK, safety, and efficacy) and/or cohort studies.
• Experience working in LMIC or training/education.
• Interest in real world data analysis, data science, modeling for clinical research.
• Experience in preparing funding applications.
• Experience with product development and regulatory processes.
• Experience with introduction and roll out of new medications.
• Ability to work remotely but collaboratively with multiple stakeholders.
• Understanding of LMIC setting and inherent challenges.
• Knowledge of 1 or more stages of the product life-cycle.
• Knowledge of standard packages for remote collaboration and project management (Word, Excel, PowerPoint, Teams, Zoom).
• Expert knowledge of English.
• Intermediate or basic knowledge of another UN language.

Purpose of consultancy

To provide targeted technical expertise to the four GAP-f related working groups, and the timely operationalization of the GAP-f 2022-2024 strategic plan”.

Background

The Global Accelerator for Paediatric Formulations (GAP-f) is a WHO Network launched in 2020 to address the Paediatric medicines gap. It is a network of 30 organizations, that works across the life cycle of drug development by bringing efficiency through enhanced coordination across stakeholders to prioritize, evaluate, develop and deliver better Paediatric medicines.

GAP-f is led by a Secretariat, which is responsible for developing and maintaining the GAP-f strategy, leading GAP-f’s advocacy work, and overall operations of GAP f. The Secretariat sits within WHO’s Research of Health Department in the Science Division, and has a coordination function, liaising with 30 external organizations as well as multiple technical departments within WHO. The GAP-f Secretariat supports the work of four working groups which are designed to gather GAP-f network members and leverage their expertise to address systemic barriers across the product life cycle. The working groups include: prioritization, clinical research, product development and regulatory affairs, and product access and treatment delivery. Working groups meet periodically to prioritize, plan and implement the working group activities in alignment with the GAP-f 2022-2024 strategic plan. The prioritization working group is lead by WHO and supports PAediatric Drug Optimization (PADO) processes across therapeutic areas led by WHO’s technical departments. The clinical research working group convenes research expertise across the GAPf network do optimize clinical research methodologies and identify integrated efforts to accelerate and increase the quality of clinical research on new medicines for children. The Product development and regulatory affairs working group gathers relevant expertise within the network to optimize best practices in product development and regulatory submission. Finally the product access and treatment delivery working group facilitates the work on the network to ensure that better formulations developed with the facilitation of GAPf are effectively introduces and rapidly rolled out.

In this context, RFH seeks to identify 1 or more consultants who will be able to support full time or part-time the activities of the Secretariat and the four working groups.

Deliverables

Task 1:

• Provide technical expertise to Prioritization Working group. This will include:
• Provide input to the revision of the Prioritization Working Group objectives and facilitate development of its work plan
• Facilitate communications and follow-up with individuals or partnering organizations on agreed actions
• Facilitate planning and running of 1 stakeholder webinar on prioritization
• Provide input to the revision of the GAP-f dashboard to monitor and track GAPf priority products and cross-cutting activities.

Deliverables 1: Meeting notes and slides-set for bimonthly WHO internal meeting and PADO support calls, draft Prioritization WG workplan, draft Prioritization WG progress report and slides-sets, draft agenda and slide sets for Prioritization webinar, draft tracking of priority products. Expected by 30 June 2022, 30 December 2022, 30 June 2023

Task 2:

• Provide technical expertise to Clinical Research Working group. This will include:
• Provide input to the revision of the Clinical research Working Group (CRWG) objectives and facilitate development of its work plan
• Facilitate communications and follow-up with individuals or partnering organizations on agreed actions
• Facilitate planning and running of 1 stakeholder webinar on clinical research priorities
• Provide input to the revision of the GAP-f dashboard to monitor and track GAP-f priority products and cross-cutting activities.

Deliverables 2: Meeting notes and slides-set for quarterly CRWG meetings, draft CRWG workplan, draft CRWG quarterly progress report and slides-sets, draft agenda and slide sets for CRWG webinar, draft tracking of priority research. Expected by 30 June 2022, 30 December 2022, 30 June 2023

Task 3:

• Provide technical expertise to Product Development and Regulatory Affairs Working group (PDRA WG). This will include:
• Provide input to the revision of the PDRA Working Group objectives and facilitate development of its work plan
• Facilitate communications and follow-up with individuals or partnering organizations on agreed actions
• Facilitate planning and running of 1 stakeholder webinar on on product development and regulatory affairs priorities
• Provide input to the revision of the GAP-f dashboard to monitor and track GAPf progress with product development and regulatory affairs on priority products for clinical research as well as with cross cutting activities priority products and cross-cutting activities.

Deliverables 3: Meeting notes and slides-set for quarterly PDRA meetings, draft PDRA workplan, draft PDRA quarterly progress report and slides-sets, draft agenda and slide sets for PDRA webinar, draft tracking of priority research. Expected by 30 June 2022, 30 December 2022, 30 June 2023

Task 4:

• Provide technical expertise to Product Access and Treatment Delivery Working group. This will include:
• Provide input to the revision of the PATD Working Group objectives and facilitate development of its work plan
• Facilitate communications and follow-up with individuals or partnering organizations on agreed actions
• Facilitate planning and running of 1 stakeholder webinar on product development and regulatory affairs priorities

Deliverables 4: Meeting notes and slides-set for quarterly PATD meetings, draft PATD workplan, draft PATD quarterly progress report and slides-sets, draft agenda and slide sets for PATD webinar, draft tracking of priority research. Expected by 30 June 2022, 30 December 2022, 30 June 2023

Task 5:

• Provide technical expertise to GAP-f Secretariat on coordination and event planning. This will include facilitating the preparation, running and follow up of:
• GAP-f’s Donor forum meetings
• GAP-f Industry forum meetings
• GAP-f Annual network meeting
• GAP-f Advisory committee meetings
• Civil society forum meetings

Deliverables 5: Draft agenda, invitations, slides-set and follow up notes for the following meetings (3 Donor forum, 1 industry forum, 2 civil society, 2 advisory committee, 1 network) Expected by September 2022, December 2022, 30 June 2023

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

University Degree in medical or social sciences.

Desirable:

Postgraduate degree in clinical epidemiology, public health or equivalent

Experience

Essential:

At least 5 years of relevant experience in managing and coordinating collaborative projects

Desirable:

• At least 5 years of relevant experience with clinical research (ie PK, safety and efficacy) and/or cohort studies;
• Experience with working in LMIC or training/education Interest in real world data analysis, data science, modeling for clinical research;
• Experience in preparing funding applications;
• Experience with product development and regulatory processes;
• Experience with introduction and roll out of new medications.

Skills/Knowledge:

• Ability to work remotely but collaboratively with multiple stakeholders
• Understanding of LMIC setting and inherent challenges,
• Knowledge of 1 or more stages of the product life-cycle.
• Knowledge of standard packages for remote collaboration and project management (word, excel, powerpoint, teams and zoom)

Languages required:

Essential:

Expert knowledge of English.

Desirable:

Intermediate or basic knowledge of another UN language.

Location

Home based – Off-site.

Travel

No travel expected

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B at 7,000-9,980 USD 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 - with possible additional contracts subject to funding and satisfactory performance

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 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

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Potential interview questions

Added 4 years ago - Updated 1 year ago - Source: who.int