- Country: Addis Ababa, Ethiopia
- No of vacancies: N/A
- Salary: N/A
- Organization: UNOPS
- Gender: Both
- Deadline: 2024-02-05
Functional Responsibilities
The Project Managment Support Officer will be responsible for the below listed tasks.
- Support the development and implementation of the 3-year EFDA transformation plan (FHRSTP II) and co-develop monitoring and evaluation tools for 3-year transformation plan of the Authority;
- Prepare/revise IDP tools (legal document, guidelines, manuals, SOPs, checklists, forms) which help EFDA for attainment of WHO maturity level 3 based on recommendations issued by WHO auditors;
- Participate in conducting EFDA internal audit and management review meeting on progress of CAPA implementation of non conformances identified by WHO auditors;
- Support the development and revision of standards, guidelines checklists which help for standardization of regulatory requirements and coordination among EFDA main office, branch offices, and regional regulatory bodies;
- Analytical support in developing/revising tools which helps medical product marketing authorization and system requirements for upgrading of the electronic regulatory information system;
- Engage in supporting establishment and implementation EFDA quality management system;
- Support the development of tools and meeting that support cGMP compliance of the local pharmaceutical manufacturers;
- Support in preparing protocols, guidelines, checklists for the conduct of inspections and post marketing surveillance of medical products;
- Support the development of tools on combating of antimicrobial resistance and enforcement of rational medicine use.
- Engage in strategic and flagship activities of EFDA;
- Coordinate with and facilitate and arrange capacity building interventions in the areas of medicine registration, WHO maturity level, inspection of GMP and GXP inspection of medicine distribution channel, and the overall regulatory system;
- Liaise between EFDA and different stakeholders including National Ethics Committee (MoE) in relation to clinical trial conducted in the country and other agencies in relation to EFDA priority areas stated in the scope of the assignment;
- Other related assignments as given by the Director general Office for operation.
Expected Deliverables
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- Technical support provided to the director general office on the implementation of the Food and health product regulatory sector transformation plan with respect medical product sector regulation
- Number of regulatory tools developed and/or revised
- Regulatory workforce supported on specific regulatory areas
- EFDA own staff are coached and mentored in different regulatory activities
- Monthly and quarterly progress report submitted
The above deliverables are only indicative and are subject to change within the scope of role.
Education/Experience/Language requirements
Education
- A first University Degree (Bachelor’s Degree or equivalent) in Public Health, Pharmacy or other related fields is required. OR
- Advanced University Degree (Master’s Degree or equivalent) in Public Health, Pharmacy or other relevant fields is desirable.
Experience
- At least two (2) years of proven experience directly related to supporting health systems strengthening and program management is required.
- Experience in demonstrating an in-depth understanding and analytical capacity across issues related to medicine regulatory system strengthening (including medicine marketing authorization) evidence-based planning, prioritization and monitoring is desirable.
- Experience working with development partners, the food and medicine regulatory system, strong understanding of GMP compliance of pharmaceutical manufacturing and Ethiopia’s health system is an added advantage.
- Expereince in promoting teamwork between EFDA and DPs is an asset.
Language
- Fluency in spoken, written and reading English is required.
- Knowledge of another UN official language is an asset.
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