U.S. Pharmacopeial Convention Jobs

Description

The Senior Technical Specialist, Regulatory Systems Strengthening (RSS) will provide technical assistance to the Agency on Development of the Pharmaceutical Industry (Agency) in Tashkent. The incumbent will support the delivery of PQM+ activities in a dynamic, fast-paced environment and is responsible for day-to-day technical implementation of PQM+ activities. The Senior Technical Specialist will have functional reporting to the Rockville based PQM+ Senior Technical Advisor – RSS and will work under their guidance with additional support from the Technical Advisors, to ensure technical approaches and strategies are applied appropriately. S/he will also liaise with donors, national counterparts, GHMS staff, and consultants to facilitate program implementation.

Roles and Responsibilities:

• Partner with the Director, Health Elements, Program Manager and Senior Technical Advisor, RSS to implement RSS technical activities as outlined in the work plan

• Provide consistent, high-quality, and results-driven technical assistance to the Agency to develop their capacity through assessment, training, document review and standardization, development and dissemination of tools and job-aids amongst others

• Provide trainings in collaboration with the Senior Technical Advisor and Technical Advisor, RSS to the staff of the Agency in regulatory functional areas as needs are identified

• Collect and report data on approved indicators as defined in the monitoring evaluation and learning (MEL) plan

• Review and provide timely inputs into key project deliverables including work plans and reports

• Contribute to defining and refining the program’s RSS strategy and approach to ensure alignment with international best-practices

• Timely preparation and submission of technical assessment and travel reports.

• Identify technical challenges and risks as well as resolve issues in collaboration with the Senior Technical advisor, RSS and other team members

• Develop and present to groups/ external stakeholders in relevant areas, including WHO, regulatory forums/ authorities, and other leaders in health system strengthening

• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports

Basic Qualifications:

• Bachelors Degree

• Four 4 years’ experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – product dossier review and registration, post-market surveillance, or inspections.

Skills Sought:

• 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 and understanding of WHO global benchmarking too

Preferred Qualifications

• Six or more years’ experience in 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

Job Category Technical Programs

Job Type Full-Time