Technical Lead

2 weeks ago

Parktown North, Gauteng, South Africa AJ Personnel Full time

Main purpose of the job:

  • Lead the drug development and regulatory processes workstream for the marketshaping 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 USbased product development and regulatory team and develop plans to accelerate generic product development
  • Work closely with CHAI's USbased 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 daytoday 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 oneonone 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 daytoday support to all project staff
  • Take ownership and accountability for tasks and demonstrate effective selfmanagement
  • 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, policysetting 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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