Pretoria: Senior Manager (Health) posted by AtripleA recruitment & temps

About the Role

AtripleA recruitment & temps is seeking a highly experienced Senior Manager in the Health Industry to join our client’s team. The ideal candidate will have a strong background in project management, regulatory affairs, and strategic planning. This role offers an opportunity to lead and manage projects, develop strategies, and contribute to the overall success of the organization.

Key Responsibilities

• 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.

• 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.

• 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

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.

• 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.

Qualifications

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Salary & Benefits

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