USP seeks consultants/vendors with expertise in one or more of the technical areas of interest below to be shortlisted for a candidate pool for potential future work in various countries throughout the Africa, Asia and Central Asia regions. Note that this is a general Call for Consultants to build a qualified applicant pool. This job posting does not guarantee employment. Consultants and firms who meet the outlined qualifications and skills listed below will be added to the USP Consultant Database for future potential engagement. Those selected to be added to the Consultant Database will be notified. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division. Applications may be made to one or more of the technical areas of interest, based on the consultant’s/vendor’s qualifications. Note that this is a remote role with possibility for travel. This is a global position and candidates worldwide are encouraged to apply. Note that this may be a remote position with possibility of travel.
TECHNICAL AREAS OF INTEREST
A) Global Standards 1 (GS1)
USP seeks Global Standards 1 (GS1) consultants to provide technical assistance to national regulatory authorities (NRAs), Ministries of Health and pharmaceutical manufacturers in low- and middle-income countries (LMICs) in the area of adoption of GS1 standards for medicines. The incumbent’s responsibility will be to provide technical guidance and training for the implementation of pharmaceutical traceability; to help sensitize the local pharmaceutical manufacturing industry and other relevant stakeholders to adopt GS1. Consultants must possess a deep understanding of the pharmaceutical supply chain, pharmaceutical regulatory environment in LMICs, GS1 standards, and be able to demonstrate successful implementation in a number of countries. They will work in coordination with technical staff at USP headquarters and in the field.
Potential tasks that the consultant/vendor will be responsible for carrying out include:
· Review the current state of GS1 standards implementation for medicines in relevant countries, identifying gaps and areas for improvement.
· Contribute to the development of national pharmaceutical traceability strategies, aligning these with global best practices.
· Design and develop training materials and conduct workshops aimed at promoting the understanding, adoption, and implementation of GS1 standards.
· Provide technical support to NRAs in developing GS1 guidelines and related documentation for successful adoption by countries.
· Develop appropriate scopes of work for the development of track and trace national frameworks encompassing:
o Proposed phases of implementation
o Key features of the multi-dimensional barcodes (e.g. 2D matrix barcode or QR code)
o Level of packaging implementation
o Serialization and aggregation
o Data management and sharing
o Any exemptions
· Propose necessary amendments to existing legislation, policies, and implementation plans in a manner that adequately supports the design and implementation of traceability architecture plans.
· Assist NRAs in developing GS1 standards implementation monitoring plans, especially the GS1 field quality reports.
· Maintain active collaboration with GS1 healthcare (global and local offices, if any) for effective planning of regulations, guidelines, and training.
· Serve as a technical Regulatory System Strengthening resource with respect to GS1 medicine standards, advocacy, and implementation.
· Contribute to the efforts aimed at the development and dissemination of USP approaches related to GS1 standards.
· Provide inputs to the development of USP technical tools relevant to GS1.
Qualifications
Master’s degree or equivalent in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field.
· Eight (8) years of experience in the healthcare supply chain, pharmaceutical regulation, and regulatory functions with hands-on experience in the adoption of GS1 standards for medicines.
· Comprehensive knowledge and understanding of the norms and practices of pharmaceutical systems in Africa and/or Asia.
· Experience designing plans for GS1 standards adoption and deployment, particularly in the LMIC context.
Demonstrated non-technical skills:
· Ability to travel internationally for up to 25% of the time.
· Excellent written and oral communication skills, including experience in training and mentoring staff.
· Fluency in English is required. Fluency in other selected languages is desirable: French, Portuguese, Spanish, or Russian.
Qualifications [List]
· Education
· Years of experience
· Knowledge of and experience with
· Ability to travel internationally for up to 25% of the time (if applicable)
· Demonstrated non-technical skills (List)
· Excellent written and oral communication skills, including experience in training and mentoring staff and others
· Fluency in English is required. Fluency in other selected languages preferred: French, Portuguese, Spanish, or Russian
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to gph_procurement@usp.org by the March 15, 2024. When submitting your application, write “Call for GS1 Consultant” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
