Medical Project Manager (Drug Development & Regulatory Processes)

Main purpose of the job:Project manage and support the drug development and regulatory processes workstream of the market shaping outputLocation:Parktown - JohannesburgKey performance areas:Project manage and support the drug development and regulatory processes workstreamTogether with the senior technical specialist, work closely with CHAI and lead product development, regulatory, and quality assurance processesTogether with the senior technical specialist, work closely with the CHAI's US-based product development and regulatory team and develop plans to accelerate generic product developmentTogether with the senior technical specialist, 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 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 workstreamAssist and support the technical specialist to convene 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 environmentSupport the technical specialist with overseeing 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 stakeholderAttend 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 activitiesTake 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 Graduate-level Medical Technical Degree with significant experience in product development, commercialization, and regulatory affairsRequired minimum work experience:Minimum 6 years of private sector work experience, with a focus on product development and commercialization and regulatory affairsExperience supporting the successful acceleration of 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 supporting efforts to:Guide 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 efficacyHelp to establish succinct regulatory filing strategies to support the filing of regulatory dossiers that demonstrate a new product's safety, efficacy, and qualitySupport the development and commercialization of drug products, drug-device combinations, and medical devicesPerform Current Good Manufacturing Practice (cGMP) gap analyses and reviewing regulatory submissions for new innovator and generic product manufacturersExperience supporting the development of strategies to overcome key barriers and issues related to product development, filing, approval, introduction, and adoptionExperience translating the above-mentioned strategies into actionable itemsAbility to collaborate remotely with team members spread across geographiesDesirable additional education, work experience, and personal abilities:Good interpersonal skills and ability to navigate complicated situations, excellent levels of written and verbal English communication skills, ability to communicate in other SA languages, preferably area-appropriateDemands of the job:Travel will be required within and outside of South AfricaWork can be highly demanding and pressurized, and requires flexibility, management, training, and leadership experienceTO APPLY:Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV. 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