Senior Technical Advisor, Regulatory Affairs (Nationals Only)
MAIN PURPOSE OF JOB
The Senior Technical Advisor (STA), provides technical assistance for preparation of regulatory submissions in accordance with applicable regulations, and coordination with relevant partner and project team members to identify and gather required documentation and data needed for regulatory recommendations for vaccine procurement modernization in the country, working as part of the country MTaPS team.
The STA provides support to the Country Program Director (CPD) and provides direct technical assistance to Ministry of Health and other country partners and stakeholders. As required, the STA also provides technical assistance to other MTaPS country activities and works with MTaPS Technical Strategy Lead and other MSH technical staff on opportunities, new and existing tools, and country implementation programs related to strengthening pharmaceutical management systems.
MAIN DUTIES AND RESPONSIBILITIES
Technical Support 40%
In coordination with the CPD and MOH counterparts, advise the legislative branch of government on required regulatory reforms to enable vaccine procurement modernization.
Coordinate with relevant government entities and project staff to identify and gather required documentation and data needed to recommend regulatory changes
Assist with reviewing documents necessary to support regulatory reforms, including budget instructions and proposal amendments, vaccine registration and procurement, briefing packages and responses to queries from the legislative branch of government and regulatory entities.
Maintain up-to-date working knowledge on relevant regulatory regulations, guidelines, and the current regulatory environment in Jordan.
Perform directed research for regulatory aspects of vaccine registration and procurement
Continuing professional development by attending regulatory-related meetings such as JFDA briefing meetings, conferences, workshops.
Work with the MOH, country stakeholders and international counterparts to help develop, review, implement, and monitor technical approaches and strategies for vaccine procurement modernization in the country in accordance with national strategies and action plans.
Provide direct technical assistance to relevant stakeholders in designing and implementing work plan activities and interventions with focus on sustainable financing of medical products including vaccines.
Lead the process to conduct a legislative review and analysis of existing vaccine registration and procurement bylaws, policies, and processes to determine potential areas of change for enhancing the efficiency and effectiveness of the vaccines procurement process
Work with Vaccines procurement modernization committee, other team members in the country and HO based technical team, to provide technical assistance for improving vaccine procurement practices
As needed provide technical support to other MTaPS pharmaceutical systems strengthening and health elements activities in the country.
Coordination and communication 25%
Coordinate with other MTaPS country project technical activities ensuring harmonized approach in line with MSH quality standards
Coordinate assigned technical areas and activities with other USAID-funded and international projects in the country
Work closely with the Head Office based Technical Lead and other technical team members for appropriate and timely technical guidance and support
Maintain close liaison with USAID mission focal point and the focal point in the MOH and JFDA on progress, challenges and way forward and provide regular update.
Capacity Building 20%
Work with country and HO based team to develop costed project capacity strengthening strategies, roll-out plans, training and follow-up timelines
In conjunction with the country team, country counterparts and HO based team, develop/revise required training packages and materials
Design, develop training packages, and conduct ToT exercises as needed
As required, participate in the planning and delivery of broader capacity building programs aimed at national pharmaceutical system strengthening.
Monitoring & Evaluation 10%
In coordination with other team members in the country and head office, contribute to the development of country project M&E plan, and support the collection and validation of relevant data to report project indicators.
Contribute to the adequate documentation and dissemination of program results and lessons learned, including the development and submission of abstracts and articles to scientific journals and conferences.
Performance Management 5%
- If needed, supervise assigned Technical Advisor(s) ensuring the adequacy of their performance and their continuous professional development.
- Bachelor's degree or higher in biological or biomedical science or in a health-related field with specialized training and/or experience in Regulatory Affairs related to registration and procurement of pharmaceuticals including vaccines.
- Regulatory Affairs Specialist, Policy and Legislative Analyst.
- At least 5 years of experience in Regulatory Affairs.
- Demonstrated understanding of the medicine development process, particularly with vaccines or biologics.
- Working knowledge of Jordanian regulations and industry standards pertaining to regulatory requirements for medicine/vaccine development and registration and public finance.
- Experience with regulatory affairs and public health programs in developing country context supported by bilateral agencies such as USAID, CDC and international agencies such as the Global Fund, UNICEF, WHO and World Bank preferred.
Knowledge and Skills
- Excellent writing and presentation skills in English are essential.
- Languages of other USAID-supported countries is an asset.
- Strong computer skills; Excel, MS Word, MS Project, PowerPoint.
- Demonstrated competence to assess priorities and manage a variety of activities in a time-sensitive environment and meet deadlines with attention to detail and quality.
- Ability to work independently and in team.
- Good judgment for decision-making.
- Strong interpersonal and communication skills; ability in consensus building and constructively leading a team.
Physical demands : Ability to travel internationally and domestically up to 30% of time as required to support the progress of program activities.
MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.