Medical Drug Development and Regulatory Processes

Description:

Main purpose of the job:Lead the drug development and regulatory processes workstream for the market-shaping outputLocation:Parktown – JohannesburgKey performance areas:Lead the drug development & regulatory processes workstreamWork closely with CHAI and lead product development, regulatory, and quality assurance processesWork closely with the CHAI’s US-based product development and regulatory team and develop plans to accelerate generic product developmentWork closely with CHAI’s US-based product development and regulatory team to assess and mitigate product development risks with generic partners and support innovative regulatory strategiesEngage in job shadowing (of CHAI) during technical meetings with generic manufacturers and strategy developmentDevelop and maintain a strong working relationship with CHAI, manufacturers, and other stakeholders as relates to the drug development & regulatory processes workstreamConvene and/or attend and lead drug development and regulatory stakeholder meetingsWork closely with CHAI to establish appropriate relationships with key stakeholders within the drug development & regulatory environmentOversee the planning and coordination of the drug development & regulatory workstreamEnsure coordination with the supplier engagement and contract management workstreamActively participate in key global, regional, and national stakeholder foraLine manage and give day-to-day direction to one project manager: drug development and regulatory processes. Dotted line management of two other positions (project administrator and project statistician)Attend manufacturer site visits as necessaryReport monthly on key achievements, challenges, and any anecdotal success storiesContribute to and support financial management and control as related to the above human resources and other activitiesPlan, convene, and produce reports for monthly one-on-one meetings with supervised staff to monitor performance and supportAttend to all staffing requirements and administrationOversee the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relationsPlan, organize and lead staff performance assessmentsIdentify substandard performance by team members and plan and implement necessary corrective actionCoach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organizationLead the promotion of harmony, teamwork, and sharing of informationProvide day-to-day support to all project staffTake ownership and accountability for tasks and demonstrate effective self-managementFollow through to ensure that quality and productivity standards of own work are consistently and accurately maintainedMaintain a positive attitude and respond openly to feedbackTake ownership of driving your career development by participating in ongoing training and development activities such as forums, conferences, policy-setting workshops, etc.Required minimum education and training:A Gradua