Senior Manager (Health)
Posted on 2025-03-08
Employer | AtripleA recruitment & temps |
---|---|
Salary | 35000 |
Category | Medical |
Location | Gauteng / Pretoria |
Job Summary
Requirements:
• 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
Knowledge:
• 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)
Competencies/ Skills:
• 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
•Personal Attributes:
• Assertive
• Self-driven
• Creative
• Customer focused
• Solution orientated
• Able to work under pressure
Duties:
• 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
• project
• 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
Senior Manager (Health) position available in Gauteng, Pretoria. This job position was posted by AtripleA recruitment & temps. The job has been posted as a free ad on 2025-03-08 at 16:11:43 in the Medical category
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