Senior Manager (Health)

AtripleA Recruitment; Pretoria; On-site; ZAR 700,000 - 900,000; Full time

Job summary

A client in the Health Industry is seeking a Senior Manager to develop and manage strategies for the Health Product Authorisation programme. The ideal candidate will have at least ten years of experience in a related field, with strong regulatory knowledge and management skills. Responsibilities include coordinating operations, preparing reports, and overseeing application processes. A bachelor's degree in a relevant field and project management qualification are required. Willingness to travel and work irregular hours is essential.

Qualifications

• Minimum ten years relevant experience; 5-7 years in middle management.
• Sound knowledge of Medicines and Related Substances Act.
• Must have a valid driver's licence.

Responsibilities

• Develop strategy and operational plans aligned with organisational needs.
• Manage the Health Product Authorisation programme operations.
• Prepare monthly, quarterly and annual reports.

Skills

General management skills

Excellent communication skills

Analytical and report writing skills

Planning and organizational skills

Performance measurement skills

Resilience and ethical behaviour

Education

Bachelor's degree in Medical, Health or Natural Science

Post-graduate degree (added advantage)

Project Management qualification

Job description

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
• 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 organisational needs and ensuring the most effective utilisation 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
• Manage 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
• Direct screening and checking of applications for administrative completeness in line with prescribed requirements
• Manage allocation of all applications to the appropriate evaluator/assessor for professional assessment within a set time frame depending on the type of application
• Set policy for tracking progress of applications and assessment by evaluators/assessors and assist assessment process to obtain additional information from applicants if requested by evaluators/assessors
• Manage receipt acknowledgement of study documentation (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 licences by relevant programmes and issue authorisation letters
• Authorise 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
• Record all approved changes in respect of medicines, clinical trials, complementary medicines, medical and in‑vitro devices, ionising and non‑ionising 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 licences 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