The U.S. Pharmacopeial Convention (USP) Senior Technical Advisor PQMPlus in Tashkent, Uzbekistan
Who is USP?
The U.S. Pharmacopeial Convention (USP) 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Technical Advisor/Senior Technical Advisor, PQM+, Uzbekistan will be responsible for ensuring technical quality and harmonization of PQM+ programs in Uzbekistan. The successful candidate will provide technical assistance to the medicines regulatory authority (MRA) of Uzbekistan in regulatory systems strengthening. The incumbent will support the delivery of PQM+ activities in a dynamic, fast-paced environment, and is responsible for day-to-day technical aspects of the PQM+ activities in Uzbekistan. The successful candidate will have reporting to the Rockville based Director, Health Elements (until Chief of Party for PQM+/Uzbekistan is hired) and will work under his guidance with additional support from the Rockville based Senior/Technical Advisors, to ensure technical approaches and strategies are applied appropriately. The successful candidate will also liaise with donors, national counterparts, GHMS staff, and consultants to facilitate technical aspects of the program implementation.
How will YOU create impact here at USP?
• Provide technical leadership in proposing and discussing new activities with the donor and beneficiaries
• Provide technical input and guidance on developing workplan, budget, and resource plans
• Partner with the Director, Health Elements, Program Manager, and technical staff of PQM+ to implement technical activities as outlined in the work plan
• Provide technical input and review in procurement and hiring decisions for the country
• Provide consistent, high-quality, and results-driven technical assistance to the MRA to develop their capacity through assessment, training, document review and standardization, development and dissemination of tools and job-aids amongst others
• Lead the development of medicines regulatory policies impacting medicine quality and work with the MRA and Ministries of Health (MoH) enabling strengthening of medicines quality assurance systems in the countries.
• Advises MRA on interventions to address institutional development plans based on the findings of WHO Global Benchmarking or PQM+ assessments of the relevant countries
• Propose new and innovative activities and approaches to address technical challenges and risks
• Provide technical input to the drafting, review, and finalization of the technical and programmatic report, communication pieces, and other documents
• Provide technical input to the drafting, review, and finalization of technical deliverables such as standard operating procedures, manuals, training materials, etc.
• Facilitate the development of in-house training programs to ensure sustainability and transfer of knowledge
• Orient technical staff and consultants supporting implementation of PQM+ program in Uzbekistan
• Provide trainings in collaboration with the PQM+ technical staff
• Advises on development of indicators, data collection plan and reports, as part of the monitoring evaluation and learning (MEL) plan
• Develop and present to groups/ external stakeholders in relevant areas, including WHO, regulatory forums/ authorities, and other leaders in health system strengthening
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Bachelor’s degree
• 10 years’ experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – product dossier review and registration, post-market surveillance, inspections, or medicines quality control
• Demonstrated experience in developing and implementing regulatory systems strengthening interventions obtained from working with national regulatory authority or with the pharmaceutical industry
• Fluent in written and spoken Uzbek and Russian languages
• Strong written (especially technical writing) and oral communication skills
• Direct experience with or understanding of WHO global benchmarking tool
Additional Desired Preferences
• Demonstrated experience working and leading various departments in a national medicines regulatory authority, pharmaceutical manufacturer or organization providing technical assistance to strengthen medicines quality assurance systems
• Twelve or more years’ experience in pharmaceutical regulatory affairs
• Working experience with assessment tools (e.g., WHO Benchmarking Tool-GBT) to evaluate key functions of a medicine’s regulatory authority
• Direct experience implementing USAID-funded programs
• Fluent in written and spoken English
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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.
Job Category Technical Programs
Job Type Full-Time