CALL FOR Regulatory Information Management System (RIMS) TECHNICAL EXPERTS
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. 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) Regulatory Information Management System (RIMS)
USP seeks a Regulatory Information Management System (RIMS) consultant to collaborate with National Regulatory Authorities (NRAs) in Low-and Middle-Income Countries (LMICs) for the planning and implementation of Regulatory Information Management Systems (RIMS), ensuring the adoption and incorporation of data standards (developed by the USAID- funded MTaPS and PQM+ programs) into the main regulatory functions of the respective NRAs. The consultant will oversee the adequate planning and deployment of RIMS in designated NRAs and will ensure that the capacity of its staff is strengthened to effectively manage and sustain such regulatory information system in a manner to facilitate national, sub-regional, and regional harmonization and reliance through regulatory information sharing.
Potential tasks that the consultant/vendor will be responsible for carrying out may include: but is not limited to:
Select and incorporate appropriate data standards of the three categories (Process (e.g., GLP, GDP and ICH Q7), Data Dictionaries and Knowledge Trees (e.g., INN, ATC, MedDRA), and Data Exchange Standards (e.g., PDF, XML and CTD) as defined in the minimum common standards for RIMS1 to facilitate the integration of existing regulatory data standards for enhanced efficiency and interoperability.
Map/assess the different processes employed by NRAs for the implementation of their regulatory functions; also, assess existing information management systems, current staff technical expertise, workflows, and governing standards, to inform the development or customization of RIMS.
Participate in the development and implementation of plans aimed at building the capacity of NRA staff and at addressing system gaps in NRAs regulatory processes in support to the adoption of RIMS.
Develop roadmap with clearly defined activity matrix for the development/adaptation and implementation/deployment of a functional web-based RIMS as well as for multiple platform and devices such as mobile phone and tablet for selected NRAs.
Oversee the development of well-defined software requirements and specifications documents.
Support the development/customization of RIMS to meet data standards, specific regulatory requirements of respective NRAs or regional regulatory authorities.
Collaborate with regional and continental regulatory bodies to align regulatory information processes and standards.
Participate in the thorough testing, including user acceptance testing, against technical requirements of the RIMS to identify and resolve issues identified during the testing and deployment.
Collaborate with the system developer to ensure data integrity, security, and confidentiality are observed throughout the system.
Oversee the development of appropriate training materials, participate in the delivery of training programs and the development of training reports.
Regularly communicate and report to regulatory bodies, stakeholders, and end-users on progress in the implementation of RIMS related activities.
Ensure appropriate system documentation and materials (e.g., source codes, databases, user manuals, testing reports, training materials and reports, etc.) and ensure their adequate handover to local counterparts assuring sustainability.
Qualifications
Advanced degree (Master’s) level education in the areas of public health, health information systems, international development, or related field.
At least 3 years of relevant experience in areas such as Web-based software development and data management, HTML/CSS Hypertext Markup Language (HTML), JavaScript/jQuery, PHP Framework, MariaDB/MySQL database
Adequate understanding of the Regulatory Information Management Systems (RIMS) within the health sector
Experience in multi-regional digital health strategies for low- and middle-income countries
Ability to design and conduct knowledge and skill-building training and demonstration workshops.
Demonstrated non-technical skills:
Ability to travel internationally for up to 25% of the time.
Demonstrated ability to work and lead with efficiency and flexibility, particularly as part of a team effort to ensure collective success.
Proven skills in preparing reports, technical documents, analysis, and presentations.
Effective interpersonal, management and negotiation skills proven through successful interaction with stakeholders including senior government officials, regional authorities, experts, and NGOs/communities.
Ability to organize the work with minimum supervision.
Excellent written and oral communication skills.
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 03/26/2024. When submitting your application, write “Call for Regulatory Information Management Systems (RIMS) Expert” 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.
