Job Description

Reporting to

Medical Director

Job Purpose

To provide strategic and operational, scientific and clinical leadership to the Companys internal and external stakeholders.

Required Learning

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.

Drivers 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 the Companys products.

Ensure all medical marketing inputs are compliant with SAHPRA regulatory requirements, Code of marketing Practice and The Companys, 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 Companys 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 Companys 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-based treatments for patients.

Gather and communicate customer and industry insights based on medical interactions.

Provide appropriate medical and research updates to internal and external stakeholders.

Budget Management

Drive budgeting process for the Medical Affairs Department within the timelines and framework provided by Group Finance.

Ensure efficiency of the budgeting process.

Support the department to manage and control monthly operational expenses and achieve cost savings for the nosiness wherever possible.

People and Strategic Leadership

Contribute to the strategy of the organization by ensuring alignment of the Medical Affairs strategy with DMD strategy and ensure actualization thereof.

Set clear performance standards and objectives and drive performance.

Actively lead by example and champion diversity and inclusion in everyday actions and decisions.

Model and entrench the values of the organization.

Proactively drive a positive performance driven culture, underpinned by positive values, collaboration, respect, integrity, accountability, ownership and delivery.

Exhibit thought leadership around new ideas, strategies, opportunities, values and culture.

Coach and develop employees.

Provide support to the Pharmacovigilance and Drug Safety Function, across all Business Units

Provide input and advice on adverse event and safety reporting.

Research and compile clinical text for safety updates to product labelling.

Review product labelling to ensure uniform application of safety updates.

Provide medical assessments and impact analysis reports.

Support pharmacovigilance audits both internal and external.

Provide support to the Regulatory Affairs and Compliance Functions, across all Business Units:

Provide input and advice to Regulatory Affairs and Regulatory Compliance to facilitate adherence to all Regulatory requirements for

The company as per the Medicines Act 101 of 1965, the Pharmacy Act

and other polices and guidelines including the Marketing Code (MCA) and those of the South African Health Products Regulatory Authority (SAHPRA), rest of Africa Health Authorities and Health Professionals Council of South Africa (HPCSA).

Provide input on clinical aspects of Regulatory submissions to SAHPRA and clinical questions raised by SAHPRA (including rest of Africa Health Authorities), resulting in seamless product registrations and variation approvals.

Provide support to the Group Quality Assurance (GQA) Function, aligned to current Good Manufacturing Practices (cGMP), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection C0-operation Scheme (PIC/S) and health Authority Guidelines including SAHPRA and rest of Africa Health Authorities.

Provide input and advice on issues and activities impacting both GQA and Medical Affairs

Provide medical assessment reports when required.

Support and collaborate on internal and external audits.

Provide support to the Research and Development (R&D) team in implementing the Companys R&D Goals to:

Ensure cost effective products are developed that meet the objectives of Medical Affairs, Regulatory Bodies, Supply Chain and Marketing in terms of quality, safety and efficacy within agreed time frames.

Ensure a steady flow of new ideas for products, processes and technologies is provided to the Business Units.

• Core Competencies
• Clinical Expertise
• Medical Affairs
• Research and Investigative Acumen
• Medical Writing and Medical Information
• Interface at all levels
• Transformation Mind-Set
• People Management
• Teamwork and Collaboration
• Proactive leadership in positive values and culture
• Networking / Liaison
• Stakeholder engagement and management
• Commercial Acumen
• Strategic Leadership
• Business and Strategic Insight
• Collaboration and Internal Business Partnering

Metamorphosis Integrated Solutions