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Assistant Research Officer
3 months ago
The KEMRI Wellcome Trust Research Programme (KWTRP) is based within the KEMRI Centre for Geographic Medical Research - (Coast). Our core activities are funded by the Wellcome Trust. We conduct integrated epidemiological, social, laboratory and clinical research in parallel, with results feeding into local and international health policy
JOB PURPOSE:
The Chanjo Hub Project is a groundbreaking initiative focused on the development and manufacturing of a candidate malaria vaccine using egg production in Ghana, coupled with innovative mRNA technology in Kenya. With the aim of combating malaria, our project brings together a diverse team of experts and collaborators to advance research and development in the field of malaria immunisation.
Description:
REPORTS TO: Principal Investigator (PhD – Postdocs and Research Fellows)
DIRECTLY SUPERVISES: Field workers, interns etc
INDIRECTLY SUPERVISES: None.
BUDGET AND RESOURCE RESPONSIBILITY: Develop project budget
JOB DIMENSIONS:
We are seeking a highly motivated and detail-oriented Assistant Research Officer (ARO) to join our team and contribute to the regulatory strengthening aspects of the Chanjo Hub Project. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements for the manufacturing of the malaria vaccine by egg production in Ghana and by mRNA in Kenya. This role will involve working with internal teams in both countries to ensure regulatory compliance, developing institutional development plans for regulatory strengthening, collaborating with National Regulatory Authorities (NRAs) to facilitate process evaluations, and evaluating the readiness or strengthening needs of National Regulatory Authorities in alignment with the WHO NRA maturity levels.
KEY RESPONSIBILITIES:
Institutional Development Plans:
Work with internal teams in Kenya and Ghana to develop vaccine regulatory institutional development plans.
Assist in the implementation of strategies to enhance regulatory capabilities within the organisations.
Regulatory Compliance Oversight:
Collaborate with internal teams in Kenya and Ghana to ensure compliance with local and international regulatory requirements for mRNA vaccine production and egg production, respectively.
Provide guidance and support to internal teams to navigate regulatory processes effectively.
Project Coordination:
Liaise with internal teams to integrate regulatory considerations into project timelines.
Coordinate with external partners and vendors (USP, GIZ, PPB and Ghana FDA) involved in the regulatory process.
Create reports and update grant reports in liaison with CHANJO hub program manager.
National Regulatory Authority Collaboration:
Work with USP to identify and document NRA gaps facilitating and providing input in meetings and workshops.
Through USP, facilitate National Regulatory Authorities in Kenya and Ghana’s understanding of the vaccine production and egg production processes.
Contribute to USP plans to evaluate National Regulatory Authority readiness or strengthening needs, in alignment with WHO maturity levels.
Documentation and Reporting:
Maintain accurate and up-to-date documentation of all regulatory activities of Chanjo hub.
Prepare and submit regular reports on regulatory progress and milestones.
Create and maintain records of meeting minutes, workshop and audit reports.
QUALIFICATIONS:
Minimum Bachelor's degree in a relevant scientific field (biology, biochemistry, pharmaceutical sciences, etc.).
Minimum two(2) years prior experience in regulatory affairs, preferably in the pharmaceutical or vaccine development industry.
DESIRABLE CRITERIA:
Knowledge of mRNA and egg-based vaccine production processes and regulatory requirements.
Familiarity with WHO maturity levels for regulatory systems.
Strong organisational and project management skills.
Excellent communication and interpersonal skills
COMPETENCIES:
Demonstrate high levels of integrity and confidentiality
Excellent interpersonal, written, presentation and communication skills
Basic analytical, problem solving and critical thinking skills;
Team working and ability to work in diverse teams
Flexibility, adaptability, multi-tasking and attention to detail
