Medical - Other Medical Pretoria FULL TIME Job Summary Our client in the Health Industry is looking to hire a Senior Manager for the vacant position in their institute. 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 AtripleA recruitment & temps Recruiter