Senior Manager (Health)
Location not available
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