Our client in the Health Industry is looking to hire a Senior Manager for the vacant position in their institute.
• A four-year bachelor's degree in Medical, Health or Natural Science, including registration with the relevant Council, complemented by a Project
• Management qualification
• A post-graduate degree will be an added advantage
• Minimum ten (10) years relevant experience of which 5-7 years of middle management with project management experience including managing teams, developing, and evaluating budgets, creating, and implementing work plans, and monitoring both project and staff Performance
• Sound and in-depth knowledge of the Medicines and Related Substances
• Act 101, 1965 as amended and the regulations pertaining to the Act and
• the Hazardous Substances Act, 1973 and its regulations.
• Sound knowledge of regulatory scientific and technical requirements
• including in-depth knowledge of the administrative processes for
• regulation of medicines, medical devices, radionuclides and electronic
• generation of ionizing and non-ionizing radiation.
• Good understanding of the pharmaceutical industry, devices, and radiation control
• Detailed knowledge of various international standards and norms.
• Good understanding of concepts of quality management systems.
• Knowledge of complaint management system.
• Comprehensive knowledge and understanding of the Public Finance
• Management Act, including proven experience in its application.
• Comprehensive knowledge and understanding of relevant legislation,
• protocols, standard operating procedures, and work instructions.
• Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of
• 1999) (PFMA), Labour Relations Act, 1966 (Act 66 of 1995) and the
• Employment Equity Act, 1998 (Act 55 of 1998)
• General management including Human Resources, budgeting, and financial management skills.
• Good planning, organisational and presentation skills.
• Performance measurement skills,
• Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills
• Research and investigation, Analytical and report writing skills; Computer skills
• Resilience and ethical behaviour
• A track record in preparation and management of strategic plans, business plans and budgeting,
• Must be willing to travel and work irregular hours
• A valid driver's licence
• Customer focused
• Solution orientated
• Able to work under pressure
• Develop strategy, an annual performance plan, operational plans and budget for the division aligned with organizational needs and ensuring the most effective utilization of resources.
• Develop and co-ordinate systems for management of all operations of the
• Health Product Authorisation programme.
• Contribute as a member of the senior management team responsible for strategic planning of the organisation to ensure the achievement of organisational objectives and meet the needs of all stakeholders.
• Prepare monthly, quarterly, and annual reports for work done within the
• Programme including monitoring of the timelines.
• Develop and manage a project monitoring tool/s to track deliverables and resources
• Develop quality measurement standards and assure quality throughout the project deliverables
• Develop systems for performance information collection to ensure
• accurate reporting of data
• Ensure efficient project management procedures are implemented to
• enable monitoring of activities and accurate reporting of progress.
• Support the collection and accurate reporting of impact data related to the
• Manages receipt of all applications (in electronic Common Technical
• Document (eCTD) format and other acceptable formats) submitted to
• The company and recording of payments from applicants.
• Directs screening and checking of applications for administrative completeness in line with prescribed requirements.
• Manages allocation of all applications to the appropriate evaluator /assessor for professional assessment (within a set time frame) depending on the type of application. This relates to the initial application and responses from applicants to recommendations following evaluation and/or assessment.
• Sets policy for tracking progress of applications and assessment by evaluators/ assessors and assist assessment process to obtain additional information from applicants if so, requested by evaluators/ assessors.
• Manage receipt acknowledgement of study documentations (change of address, ethics committee approval letters for the study and protocol amendments, updated professional information, updated malpractice
• insurances, registration with the HPCSA, Change in investigators, study staff, study coordinators, monitors, sponsors, etc.)
• Oversee feedback to applicants of decisions regarding applications and licenses by relevant their Programmes and issue of authorisation letter
• Authorisation of changes to electronic document management system (EDMS) and electronic common technical document (eCTD) parameters to ensure control over procedures, methods, and correctness of system technical content.
• Recording of all approved changes in respect of medicines, clinical trials, complementary medicines, medical and in vitro devices, ionizing, and nonionizing radiation emitting devices; and radioactive nuclides in relevant registers (new registrations and all amendments).
• Oversee record of approved proprietary names in a central database.
• Direct processing and issuing of licenses to medicine manufacturers, wholesalers, and establishments in the country.
• Approve and ensure publication of registrations approved in the Government Gazette and forwarding to the person responsible for publication on the website
• Train and manage managers reporting to this role to ensure they have the skills required by the organisation and can achieve their performance objectives