BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to protect life. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Head of Medical Affairs to join a goal-oriented team QUALIFICATIONS NEEDED Required Qualifications MBChB or equivalent PhD minimum Preferred Qualifications Postgraduate qualification in clinical medicine or business administration Recognition is given to Prior Learning and practical experience. Experience Needed to Deliver the Role Seamlessly Required Experience At least 8 years' experience in clinical affairs and clinical trial management. At least 3 years' experience at senior management level in strategic engagement with Key Opinion Leaders in Clinical Medicine. At least 3 years of Pharmacovigilance experience Operational planning. Project management Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources. Experience in quality and regulatory compliance within a cGMP facility. Business and operational planning. Program and project management Participation in developing a departmental budget and monitoring expenditures for multiple projects and funding sources. Preferred Experience Strong background in the vaccine / biotech / pharmaceutical sector specializing in medical/medico-marketing functions, working knowledge of Pharmaceutical Manufacturing related legislation Experience in strategic engagement with International Key Opinion Leaders in Clinical Medicine Experience in having faced successfully local and/ or international quality audits. Demonstrable experience in clinical trial management and publications. Knowledge of SA healthcare pharmaceutical regulation. Strong communication and relationship building skills. Highly analytical mind and strong attention to detail. Key Duties & Responsibilities Setting up of Medical Affairs section that supports Biovac and the Kahma Group of companies. (Supports WHO pre-qualification, local and export legislation) Identify, implement and maintain group wide Medical Affairs Policies and procedures that supports clinical trials for new and existing products. Clinical trial management and co-ordination for company's project. Core Technical Delivery Responsible for all stages of clinical development of company's project including CRO / other vendors selection (with Procurement, Bids & Contracts) and CRO day to day management including study design, initiation and monitoring protocol development coordination, biostatistics and clinical study reports supervision. Medical communication between the company and external stakeholders such as HCPs, professional organizations, disease state advocacy groups patients and health authorities Provide Medical information for vaccines and providing insight into the commercial development of products. Provide scientific input, expertise and review in the design and construction of all promotional materials, DHCP letters, package inserts, market research, advisory boards and events. On request present relevant scientific information at marketing / scientific related functions. Respond promptly with medical investigations for ADR's / PVRM within the prescribed applicable regulatory timeframes Follow up with medical professionals on queries and investigations. Provide Medical oversight for Pharmacovigilance Risk Management plans for the introduction of new registrations into markets. Contractual oversight: Ensure appropriate medical agreements are in place with Contract Giver / Contract Acceptors and that they are regularly reviewed and maintained. Identify / Implement / Ensure / Provide on-going Product training for employees and healthcare providers. Build effective relationships with the Clinical section of the MCC to ensure corporate objectives are met. Implement and maintain appropriate SOP's that will ensure compliance and support of routine and clinical trial. Prepare for audits and have plan of action in place before audits. Establish an annual Medical Affairs budget Ensure Medical Affairs services are delivered to all internal and/ or external stakeholders as defined and as per departmental and/ or business calendar. Actively engage all non- performance issues regarding service delivery Carry out responsibilities in accordance with the organizations' policies, industry standards and applicable laws. Technical Competencies Required Processes Development and Review Intermediate proficiency in Microsoft Word, Excel, Power point and Project. Metric & KPI development Technical Report Writing Operational Costing & Budgeting Statistical Literacy Coaching & Mentoring of peers & staff Excellent understanding and working knowledge of Medical Affairs and systems Detailed knowledge of pharmaceutical industry standards and guidelines in GMP Documentation Management. Inventory Management Environmental, Health & Safety Management Statistical Trending & Data Analysis Metric Development & Report Writing Coaching & Mentoring of peers & staff Review & Auditing Skills #J-18808-Ljbffr