Technical Lead

2 months ago

Parktown, South Africa AJ Personnel Full time

**Main purpose of the job**:

- Lead the drug development and regulatory processes workstream for the market-shaping output

**Location**:

- **Parktown - Johannesburg**

**Key performance areas**:

- Lead the drug development & regulatory processes workstream
- Work closely with CHAI and lead product development, regulatory, and quality assurance processes
- Work closely with the CHAI’s US-based product development and regulatory team and develop plans to accelerate generic product development
- Work 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 strategies
- Engage in job shadowing (of CHAI) during technical meetings with generic manufacturers and strategy development
- Develop and maintain a strong working relationship with CHAI, manufacturers, and other stakeholders as relates to the drug development & regulatory processes workstream
- Convene and/or attend and lead drug development and regulatory stakeholder meetings
- Work closely with CHAI to establish appropriate relationships with key stakeholders within the drug development & regulatory environment
- Oversee the planning and coordination of the drug development & regulatory workstream
- Ensure coordination with the supplier engagement and contract management workstream
- Contribute to the technical coordination between Wits RHI, Unitaid, CHAI, and all other stakeholders and ensure that Wits RHI is represented
- Support optimal communication between and across the Wits RHI and CHAI teams is optimal and that program activities are coordinated and leveraged
- Contribute to the achievement of Wits RHI’s corporate goals and objectives. Actively participate in key global, regional, and national stakeholder fora
- Line 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 necessary
- Report monthly on key achievements, challenges, and any anecdotal success stories
- Contribute to and support financial management and control as related to the above human resources and other activities
- Manage line reports in keeping with Wits RHI policies and procedures
- Plan, convene, and produce reports for monthly one-on-one meetings with supervised staff to monitor performance and support
- Attend to all staffing requirements and administration
- Oversee the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relations
- Plan, organize and lead staff performance assessments
- Identify substandard performance by team members and plan and implement necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Lead the promotion of harmony, teamwork, and sharing of information
- Provide day-to-day support to all project staff
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take 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 Graduate-level Technical Degree with significant experience in product development commercialization and regulatory affairs**

**Required minimum work experience**:

- **Minimum 8 years of private sector work experience, with a focus on product development and commercialization and regulatory affairs**:

- **Successful experience accelerating preclinical and clinical research and product development by implementing efficient and effective drug development and regulatory strategies for these products. This should include specific experience**:

- **Guiding companies/partners to perform various types of bioequivalence (BE) studies, pharmacokinetics/pharmacodynamics (PK/PD) studies, and randomized controlled clinical trials (RCT) to assess safety and efficacy**:

- **Helping to establish succinct regulatory filing strategies to support the filing of regulatory dossiers that demonstrate a new product’s safety, efficacy, and quality**:

- **Supporting the development and commercialization of drug products, drug-device combinations, and medical devices**:

- **Performing Current Good Manufacturing Practice (cGMP) gap analyses and reviewing regulatory submissions for new innovator and generic product manufacturers**
- **Experience developing strategies to overcome key barriers and issues related to product development, filing, approval, introduction, and adoption**:

- **Extensive experience managing relationships with ma

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