The U.S. Pharmacopeial Convention (USP) Technical Advisor, Information Systems in Rockville, Maryland
Summary of the Position
The Technical Advisor, Information Systems, is a key technical position within the Promoting the Quality of Medicines Plus (PQM+) program. The Technical Advisor leads the design, development, and implementation of all information systems-related interventions to support the delivery of PQM+ Program work plan activities. The incumbent will manage the current inventory of PQM+ electronic tools, lead efforts to adopt external tools relevant for PQM+ work, and lead effort to improve adoption of data standards in PQM+ technical assistance. The position also facilitates the use of existing and emerging electronic tools and software applications to improve the delivery of PQM+ interventions. These tools include, and are not limited to, the Risk-based Post-Marketing Surveillance (RB-PMS)’s Medicines Risk-Surveillance (MedRS); Neglected Tropical Diseases Medicines Information Dashboard (NTD MID); the substandard and falsified medical products costing model (SF Cost Model); the Medicines Quality Monitoring Data-base (MQDB); and Risk-based Inspections (Good Manufacturing Practice Risk-Based Evaluation Tool (GREAT); and Good Distribution Practice Risk-based inspection GDP-RBI). These tools and technologies are mean to increase consistency, productivity and efficiency of PMQ+ technical operations and support in the short-, medium and long-terms. The primary end-users and beneficiaries of these tools and applications are the national medicines regulatory authorities (NMRAs) in LMICs. The tools are/will be hosted and maintained at the USP/PQM+ website. It is critical that they are well-maintained, secured, properly backed up, monitored, and trouble shout should any software application issues arise. The role of this incumbent will be involved in all stages of the tool/software development lifecycle (i.e. from technological needs determination, requirements analysis, design and implementation, through to testing, hosting, maintenance and in some cases transfer to the country clients).
Roles and Responsibilities
Leads the management of all PQM+ electronic tools and databases including - MedRS, GREAT, GDP-RBI, laboratory stepwise assessment tool toward accreditation (SATTA), MQDB, NTD Medicines Information Dashboard, IRIMS and facilitate the adoption of data standards – electronic Common Technical Dossier (eCTD), Identification of medical product (IDMP), Global Substance Registration System (GSRS), Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD), Medical Dictionary for Regulatory Activities (MedDRA), etc. within PQM+ implementation.
Leads the design, development and implementation of information systems interventions to support the delivery of PQM+ products
Supports technical teams in advancing the adoption of international data standards to support regulatory and quality assurance technical assistance
For existing and being developed tools/applications:
• Coordinates and consults with the technical teams to determine requirements for enhancing the tools’ features and functionalities for optimizing the capacity and capability, user-friendliness for scaling up their adoption and institutionalization
• Works USP IT teams (e.g. Software Configuration & Support, and Digital &Innovation Informatics) on the design and implement of requirements identified, tests run and releases the tools/software applications to relevant clients
• Performs system analysis and adjusts the design and liaise with users to ensure the developed information systems meet users’ requirements and needs
- For new or emerging tools/applications:
• Leads the planning and coordination for electronic tool/software development initiatives, to come up with innovative solutions to complex problems, and to drive concepts through to practical realization with the aim to optimize PQM+ technical program delivery with respect to regulatory systems strengthening (RSS), chemistry, manufacturing and control (CMC) and laboratory support and services (LSS), etc.
• Leads the relevant consultant application developer, where applicable, in software engineering to ensure interoperability between software applications. This may entail database design and development, data curation, data access and release through application logic and user interface with visualized graphic representation
• Designs interactive and novel user interfaces for increasing functionality and user-friendliness, and analysis of complex scientific and technical data e.g. RB-PMS data, MQDB data, and SF Cost Model data
Keeps abreast of up-to-date information, communication and technology (ICT) knowledge and expertise to maintain and improve developed tools/applications’ functionalities and user-friendliness to meet end-users needs
Serves as the focal point for obtaining latest data from relevant data source partners, validates and updates database and dashboard periodically
Forms part of the developed tools/applications administrative team for evaluating and granting access permission to clients
Develops standard operating procedures and documentation relating to informatics and data management and provides updates and reports to the management team
Works closely with all technical leads within PQM+ and Global Health and Manufacturing Services (GHMS)’s Senior Director - Global Health Technical Programs, PQM+ regional and country technical leads as well as relevant multiple regional and global partners in regulatory information management systems to advance our work in the digitalized world
Performs additional assignments as the PQM+ program evolves
Interfaces regularly with external stakeholders, including World Health Organization (WHO) relevant teams; Medicines, Technologies, and Pharmaceutical Services Program (MTaPS), and PQM+ Core and Technical partners
• Bachelors degree in health or pharmaceutical or life sciences
• Five (5) years related experience
• Demonstrated experience with information systems and data management using tools to facilitate key functions and practices of a medicines regulatory authority
• Conversant with computer programing, including Java and PHP programming.
• Experience in excel and web-interface application (development, testing and operations), data-base design/development, dashboard development and data management
• Working experience with assessment tools (e.g., WHO Global Benchmarking Tool – GBT) to evaluate key functions of a medicines regulatory authority
• Advanced knowledge in pharmaceutical data standard dictionaries e.g. Anatomical Therapeutic Chemical (ATC) and International Nonproprietary Name (INN); Data Exchange Standards pertaining to information and communications technology (ICT) and information management system (IMS) which define a common standard for health systems data transmission and exchange
• Excellent interpersonal skills, with the ability to work with people at all levels of seniority in USP and PQM• Masters degree pharmacy, pharmaceutical sciences, public health, computer Science, computer engineering or related field
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP offers an impressive benefits package, including:
· Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start
· An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
· Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time