johannes smith

* Responsible for taking a novel medical device to market. * Facilitating the process of regulatory approvals and certification (CE, ISO, etc.). * Establishing distribution channels, both within South Africa and internationally. * Negotiation and finalisation of distribution contracts and SLA’s in order to ensure that commercialisation is achieved on a global scale. * Overall responsibility for all day-to-day business operations, including but not limited to sales, marketing, strategy and financials for the company. * Mentor and develop business acumen in shareholders.

* Managing all proposals including the request and coordination of operational input which entailed drafting of budgets and incorporating all components into text proposals within early phase drug development in South Africa, consisting of three early phase clinical units. * Drafting and finalising all study related contractual agreements for all awarded proposals including client and external service level agreements on both program and project basis. * Managing regional revenue, conducting forecasts, controlling credit and managing contractual matters related to contracted studies. * Supervising and training personnel as well as coordinating and administering the bioequivalence and clinical studies at regional level. * Providing evaluation and adaption of relevant current SOP’s and business processes as well as establishing new ones, where required. * Mentoring the regional teams in order to enhance professional development and develop leadership capabilities within the team.

* Managing all proposals including the request and coordination of operational input which entailed drafting of budgets and incorporating all components into text proposals within early phase drug development in South Africa, consisting of three separate early phase clinical units. * Drafting and finalising all study related contractual agreements for all awarded proposals within the region. * Managing regional revenue recognition, managing revenue forecasts, project related credit control as well as managing contractual matters related to all contracted studies within the region. * Supervising and training personnel. * Coordinating and administering the bioequivalence and clinical studies at regional level. * Establishing and maintaining a mentoring culture within the regional team in order to ensure continues learning experiences are share within the team as well as within the organisation. * Providing evaluation and adaption of relevant current SOP’s and business processes as well as establishing new ones where required.

* Managing all proposals including the request and coordination of operational input which entailed drafting of budgets and incorporating all components into text proposals within early phase drug development in the Bloemfontein unit. * Drafting and finalising all study related contractual agreements for all awarded proposals, including sponsor and service level agreements. * Managing regional revenue, conducting revenue forecasts, project related credit control as well as managing contractual matters related to all contracted studies within the organisation. * Supervising and training personnel. * Coordinating and administering the bioequivalence and clinical studies. * Establishing and maintaining a mentoring culture within the team in order to ensure continues learning experiences are share within the team. * Providing evaluation and adaption of relevant current SOP’s and business processes as well as establishing new ones where required.

* Designing, budgeting, managing resources and coordinating clinical studies. * Managing daily operations entailing managing relationships with stakeholders at senior management level on a project and program basis. * Managing and overseeing the team in all day-to-day study related matters. * Leading a range of studies in pharmacokinetic, pharmacodynamic, proof-of-concept, bioequivalence and clinical studies in both healthy volunteers and various patient groups, including but not limited to hypertensive, osteoporosis and diabetic patients. * Directly participated as project manager in various clinical studies. * Providing assistance in evaluation and adaption of relevant current SOP’s and business processes as well as establishing new ones, where required.

Areas of responsibility included design, budgeting, resource planning and coordinating of both generic and clinical studies. Active participated as a project manager in 19 clinical and bioequivalence studies.

Areas of responsibility included design, budgeting, resource planning and coordinating of generic studies. Active participated as a project manager in 22 bioequivalence and clinical studies.

Areas of responsibility: included the assessment and treatment of patients in the following clinical areas: intensive care, internal medicine, adult neurology, neurosurgery, pediatrics and neonatology, general surgery and burns, gynecology, urology, traumatology, orthopedics and spinal unit and general out-patients clinics.

Areas of responsibility: included the assessment and treatment of patients in the following clinical areas: Intensive Care Units: medical high-risk, medical, multidisciplinary, neonatal, neurosurgical, paediatric and surgical. Wards: burns, gynaecology, urology, traumatology, medical, orthopaedics, out patients, neonatal, adult neurology, neurosurgery, paediatrics, spinal and surgical patients.