Roster of Consultants - The International Pharmacopoeia at World Health Organization

Purpose of consultancy

To develop, establish, publish and promote monographs on priority medicines (e.g. listed in the WHO Model List of Essential Medicines, recommended by specific WHO disease programmes, medicines for children, products included in the expression of interest for WHO Prequalification), active pharmaceutical ingredients and excipients, as well as general chapters, general notes, operating procedures, best practices, policies and strategies (including the work plan) for The International Pharmacopoeia.

Deliverables

Output 1: Develop, establish, revise, publish and promote monographs on priority medicines (e.g. listed in the WHO Model List of Essential Medicines, recommended by specific WHO disease programmes, medicines for children, products included in the expression of interest for WHO Prequalification), active pharmaceutical ingredients and excipients, as well as general chapters, general notes, operating procedures, best practices, policies and strategies (including the work plan) for The International Pharmacopoeia to facilitate progress toward Universal Health Coverage (UHC), including access to safe, quality, effective and affordable essential medicines for all. These outputs should be relevant/applicable to all WHO Member States and scientifically justified in a suitable format for public consultation or consideration by the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).

• Deliverable 1: Monographs and technical documents (general chapter, general notes, operating procedures, best practices, policies, and strategies (including the work plan) for The International Pharmacopoeia relevant/applicable to all WHO Member States and scientifically justified in a suitable format for public consultation or consideration by the ECSPP.
• Deliverable 2: Peer-review monographs and technical documents for The International Pharmacopoeia for clarity, accuracy, correctness, comprehensiveness, scientific quality and compliance with pharmacopoeial standards and best practices and requirements for The International Pharmacopoeia to ensure suitability for public consultation or consideration by the ECSPP.
• Deliverable 3: Technical report with ratings (on relevance and importance) and proposed action/resolution for each comment received from public consultation or ECSPP on the draft technical document.
• Deliverable 4: Presentation of the comments received from public consultation or ECSPP on the technical documents for The International Pharmacopoeia to a group of experts for peer-review, discussion and consensus.
• Deliverable 5: Revised monographs and technical documents for The International Pharmacopoeia incorporating the relevant feedback from other experts and public consultation in a suitable traceable format. 
• Deliverable 6: Final monographs and technical documents incorporating all the changes agreed upon during the final discussion leading to adoption by ECSPP and editorial changes in a suitable format for publication in the relevant edition of The International Pharmacopoeia.
• Deliverable 7: Presentation of the draft or adopted monographs and technical documents for The International Pharmacopoeia at consultative or advocacy meetings with key stakeholders.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree (Masters level or above) in Pharmaceutical Sciences or analytical chemistry or related fields.

Desirable:

• PhD in Pharmaceutical Sciences or analytical chemistry or related fields.    

Experience

Essential:

• For band level C: Over ten years of relevant experience in the pharmaceutical, life sciences, or other health-related fields. Hands-on experience in an analytical quality control laboratory, including analytical method development and validations and/or preparation or evaluation of the quality part of marketing authorization applications.
• For band level D: Over 15 years of relevant experience in the pharmaceutical, life sciences, or other health-related fields. Hands-on experience in an analytical quality control laboratory, including analytical method development and validations and/or preparation or evaluation of the quality part of marketing authorization applications.

Desirable:

• Relevant experience in a standard-setting environment.

Skills/Knowledge:

• Good knowledge of pharmaceutical regulatory requirements (e.g., CTD Module 3). 
• Strong technical knowledge in pharmaceutical quality control and pharmacopoeial affairs. 
• Strong technical knowledge in WHO and other internationally recognized quality assurance standards and health product regulations.
• Excellent technical writing skills. 
• Good communication and interpersonal skills, with the ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders. 
• Strong methodological and analytical skills, with the ability to conduct research, identify and analyze literature relevant to the programme area. 
• Good planning and organizational skills, attention to detail and the ability to multi-task and work under pressure. 
• Strong IT skills: Word, Excel, presentation software, databases and web navigators.

Closing Date: Jul 20, 2022