Head of Medical Affairs

SUMMARY:
HEAD MEDICAL AFFAIRS - Current registration with the Health Professional Council of South Africa

POSITION INFO:

HEAD MEDICAL AFFAIRS

Salary: R 2mill per annum

REPORTING TO MEDICAL DIRECTOR

JOB PURPOSE To provide strategic and operational, scientific and clinical leadership to all internal and external stakeholders.

REQUIREMENTS

• MBBCH/MBChB
• Current registration with the Health Professional Council of South Africa (HPCSA).
• Post graduate qualification in Business Management
• Experience in the medical and pharmaceutical industry
• At least 4 years of experience in the pharmaceutical industry, particularly in the areas of Medical Affairs, Medical Information, Medical Writing, Market Access.
• At least 4 years clinical experience, with extensive disease and product knowledge.
• Knowledge of regulatory rules and processes.
• Knowledge of clinical trial rules and processes
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of Pharmaceutical Marketing Ethics and Codes.
• Strong personal commitment to customer focus, accountability and excellence.
• Excellent interpersonal communication, negotiation and advanced presentation skills.
• Regulatory, Quality Assurance and Pharmacovigilance experience will be highly beneficial.
• Valid Driver's license

KEY JOB OUTPUTS

Provide leadership and overall strategic direction to the Medical Affairs function, ensuring optimal delivery in areas of Medical Information, Medical Writing, Market Access, Risk Assessments and Internal and External Stakeholder Relationships:

• Developing and executing cutting-edge medical and scientific strategies that align with the company's objectives, while overseeing all medical and scientific activities within the organization to ensure compliance with ethical and medico-legal requirements.
• Management and oversight of the Medical Affairs Function, maintaining departmental performance for all direct reports, including reporting of qualitative and quantitative performance measures, with respect to operational activities and human capital activities.
• Provide support in management of Relicare Medical Affairs (India), employees ensuring all departmental goals and deliverables are timeously met.
• Provide Business Units with evidence-based medical support.
• Ensure that all internal and external requests for medical information are managed, processed, analysed and formally responded to in writing within timelines.
• Ensure quality and timely turn around for literature reviews, and reviews of professional information, patient information leaflets, promotional material, educational material, marketing aids, labels, artwork and medical risk reports, Periodic Safety Update Reports and Risk management Plans.
• Ensure consistent and robust medical information support for marketing and sales to maximize product uptake and ongoing, sustainable growth.
• Provide Business Units, New Business Development and Market Access appropriate and evidence-based medical support.
• Provide input to Market Access to support engagement with private and state healthcare funders to ensure reimbursement/formulary inclusions for optimal patient access to organisation's products.
• Ensure all medical marketing inputs are compliant with SAHPRA regulatory requirements, Code of marketing Practice and the company's, mission, vision and values.
• Provide medical support to Pharmacovigilance, Regulatory Affairs, Group Quality Assurance and Research and Development when required.
• Provide proactive input into medical strategy, medical-marketing initiatives and medical programs to drive the company's products and product pipeline, aligned with company values, objectives and policies, in compliance with local laws and regulations.
• Prepare and compile medical resources, product scientific data, clinical articles, publications, studies and presentations.
• Co-ordinate Advisory Boards/Consultancy Panels when required
• Provide medical training and education to internal and external stakeholders.
• Conduct regular scanning and assessment of industry and legislative requirements, policies, guidelines, government discussion papers and form and present opinion on possible impact on the company with regard to Medical Affairs.
• Advise the business and make recommendations to mitigate risk or adverse impact of changes in industry and regulatory frameworks as relevant to Medical Affairs.
• Stakeholder Engagement and Management (This is a high-level position that demands a confident, assertive, highly collaborative, individual with a clear vision for managing all aspects of Medical Affairs, fully aligned with the mission, vision and values of the company)
• Act as an advisor to key stakeholders within the business, providing clinical guidance and direction in terms of medical affairs.
• Develop effective professional relationships and collaborate with healthcare professionals, societies and institutions across South Africa to drive cost effective and evidence-bas