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Senior Manager (Health)

Location not available
Senior Manager
35 000

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

 

Posted 2020-07-27

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