U.S. Pharmacopeial Convention (USP) Nigeria
Senior Technical Officer, Regulatory Systems Strengthening (RSS) at U.S. Pharmacopeial Convention (USP). Please make sure you read through the job requirements before applying.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
At USP everything we do is in service of our mission to help protect and improve the health of people around the world. From the standards we create to the partnerships we foster, we continually work to build and reinforce a foundation that draws us closer to a world where everyone can be confident of quality in health and healthcare.
Job Title: Senior Technical Officer, Regulatory Systems Strengthening (RSS)
Supervisory Responsibilities: None
Summary of the Position
- The Senior Technical Officer, Regulatory Systems Strengthening (RSS) will provide technical assistance to medicines regulatory authorities (MRAs) and Ministries of Health in francophone countries in West Africa.
- The Senior Technical Officer will work closely with Senior Technical Advisors and Technical Advisors as part of the PQM+ Center of Excellence to ensure the PQM+ technical approaches and strategies are appropriate for francophone countries in West Africa.
- The Senior Technical Officer, RSS is a regional role and will therefore have functional reporting to the Senior Technical Advisor, RSS based in Rockville.
- The incumbent will lead the delivery of PQM+ activities in West African countries. A primary focus of the role will be the implementation of risk-based approaches including post-market surveillance.
Roles and Responsibilities
- Leads in the roll-out of risk-based post-marketing surveillance in west African countries
- Identifies gaps in key medicines regulatory functions and recommends areas of improvement
- Provide guidance in the development and implementation of institutional development plans to address findings from WHO Global benchmarking assessments
- Identify and access trends in medicines regulatory activities
- Leeds in organizational and human capacity building efforts across select regulatory functions
- Liaises with medicines regulatory authorities and laboratories in francophone countries to facilitate information sharing related to medicine quality assurance
- Contributes to the development of PQM+ strategies applicable to francophone countries
- Supports the PQM+ program team in work plan development, implementation and reporting
- Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
- Provide oversight for local RSS staff, local partners and consultants involved in the regulation of medical products
- Actively engages with the WestAfrican Health Organization (WAHO) and other initiatives in the regions
- Prepares and shares analytical results and insights with national medicines regulatory authorities, ministries of health, and local USAID missions.
- May support national quality control laboratory efforts to improve quality management systems and overall testing capacity.
- Actively contribute to the annual programmatic and resource planning process and to the development of quarterly and annual reports.
- Eight (8) years experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – post-market surveillance, dossier review or inspections.
- Working knowledge and understanding of regulatory systems strengthening in francophone countries in Africa
- B.Sc in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field of study required
- Fluent in French – written and oral.
- Strong written (especially technical writing) and oral communication skills
- Direct experience with and understanding of WHO global benchmarking tool
- Willingness to travel at least 25% of the time.
- Experience in at least one of the following health areas: HIV/AIDS, malaria, TB, NTDs, AMR, MNCH
- Direct experience implementing USAID-funded programs
- Minimum of 3+ years of people management experience and skills.
1st January, 2021.
Method of Application
Interested and qualified candidates should send their Resume to: [email protected] using the Job Title as the subject of the mail.
Equal Opportunity / Affirmative Action Employer:
- Employment selection and related decisions are made without regard to sex, race, age, disability, region, 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.
Note: Only candidates with relevant qualifications will be shortlisted.
To apply for this job email your details to GPHNigeriaRecruitment@USP.org