Job Description

Division
Medical Affairs
Department
Medical Affairs
Sub Department 1
Medical Affairs
Job Purpose
Provide strategic medical leadership and scientific support to cross-functional teams, ensuring alignment with business objectives and regulatory standards, and enhance patient outcomes
Key Accountabilities (1/5)

• Stakeholder Engagement:

Manage engagement with external stakeholders relating to Medical Intelligence to understand current clinical practices, obtain medical guidance and maintain up-to-date knowledge in respective therapy areas, in order to provide valuable insights and medical support to the business

• Build and maintain relationships with Key Opinion Leaders (KOLs), medical associations, and healthcare professionals.
• Respond promptly to medical inquiries from stakeholders, ensuring accurate and timely information sharing.
• Organize and facilitate advisory boards, expert panels, and scientific events.
• Leverage KOLs for strategy development, training and understanding therapy landscape.

Key Accountabilities (2/5)

• Knowledge and Development

Ensure the medical team stays current with evolving standards to support informed decisions, regulatory compliance, and business growth through proactive, expert-driven knowledge management

• Maintain up-to-date expertise in therapeutic areas by monitoring legislative, regulatory, and industry changes.
• Attend CPD events and track emerging medical trends to inform strategy and innovation.
• Provide expert input for special projects and ensure regulatory updates (indications, dosage, safety) are implemented promptly and accurately.

Key Accountabilities (3/5)

• Compliance

• Ensure all medical activities meet current legal, regulatory, and ethical standards, supporting business objectives and safeguarding patient safety.

• Review and approve promotional, educational, and training materials.
• Oversee Patient Support Programmes (PSPs) to ensure regulatory compliance.
• Approve regulatory documents (e.g., package inserts).
• Participate in audits and ensure corrective actions are implemented.
• Manage medical budget and ensure alignment with approved allocations.
• Oversight of Pharmacovigilance activities conducted by the Qualified Person for Pharmacovigilance (QPPV) or deputy QPPV.

Key Accountabilities (4/5)

• Medical Strategy Input

Contribute to medical affairs plans and help clarify business opportunities

• Develop and execute medical affairs plans aligned with business objectives.
• Analyse and interpret clinical data to inform product positioning and strategy.
• Prepare and review scientific and promotional materials for accuracy and compliance.
• Deliver medical training to internal teams and healthcare professionals.
• Identify therapeutic gaps and recommend new molecules, devices, or incremental innovations to strengthen the product portfolio, using market analysis

Key Accountabilities (5/5)

• Team Capability

Develop people capabilities to build a goal oriented team

• Develop content and material for medical trainings of internal team and sales team
• Develop induction training program with content for new team members
• Track effectiveness of trainings regularly by means of feedback from the team as well as ROI achieved from them

Long Description
Major Challenges

• Keeping Pace with Market Dynamics and Information Overload: Rapid advancements in science and medicine require continuous learning and adaptation to remain relevant and credible.
• Regulatory Complexity: Navigating evolving, region-specific regulations and ensuring consistent compliance to minimize legal and reputational risks.
• Digital Transformation & AI: Rapid adoption of digital tools and AI for insights, stakeholder engagement, and decision-making, with a focus on ethical and accurate use.
• Measuring Impact: Developing robust metrics to demonstrate the value and impact of medical affairs activities on clinical practice and business outcomes.
• Suboptimal Medical Insight Collection: Ineffective CRM adoption and fragmented data systems reduce the ability to gather and act on valuable field insights

Key Interactions (1/2)

• Regulatory Affairs - Provide scientific input for dossier submissions and regulatory communications.
• Marketing & Sales - Review and approve promotional materials; support strategy with medical insights.
• Pharmacovigilance / Drug Safety - Collaborate on adverse event evaluations and safety reporting.
• Training Department - Develop and deliver clinical and product training for internal teams.
• Legal & Compliance - Ensure all medical activities and materials meet legal and ethical standards.
• Quality Assurance (QA) - Address product complaints and ensure quality standards.
• Portfolio & Business Development - Evaluate new products and provide medical input for pipeline decisions.
• Corporate Communications - Review public-facing content for scientific accuracy.

Finance / Procurement - Align on budget planning and vendor contracts
Key Interactions (2/2)

• Key Opinion Leaders (KOLs) - Engage for advisory boards, CME events, and strategic insights.
• Healthcare Professionals (HCPs) - Provide product information and gather feedback on clinical use.
• Regulatory Authorities - Communicate on product approvals, safety updates, and compliance.
• Professional Societies - Participate in guideline development and scientific forums.
• Patient Advocacy Groups - Understand patient needs and support educational initiatives.
• Government & Public Health Officials - Align with national health priorities and policy developments.
• Health Funders / Payers - Provide pharmacoeconomic data to support formulary inclusion.

Dimensions (1/2)

• Therapeutic Scope

• HIV (ARVs), Anti-infectives, Cardiovascular, Dermatology, Gastroenterology, Hospital, Immunology (including Biosimilars), Metabolic, Neurology, Oncology, OTC and CAMs, Pain, Psychiatry, Respiratory, Vaccines, and Women's & Men's Health.
• Geographic Reach

• Primary responsibility for South Africa (SA).
• Strategic support for Sub-Saharan Africa (SSA) and North Africa, contributing to regional medical strategy and operational frameworks.
• Team Leadership

• Oversight of a cross-functional medical team.
• Involvement in recruitment, training, performance management, and capability development.
• Budget Responsibility

• Preparation and management of the medical affairs budget.
• Ensuring alignment with strategic priorities and compliance with financial controls.
• Strategic Influence

• Input into portfolio development, product launches, and lifecycle management.

Collaboration with commercial, and regulatory teams to align medical strategy with business goals.
Dimensions (2/2)
Key Decisions (1/2)

• Strategic & Scientific Decisions
• Approval of medical content for promotional, educational, and training materials.
• Planning and endorsement of Continuing Medical Education (CME) activities.
• Scientific input into product positioning, lifecycle management, and launch strategies.
• Evaluation and recommendation of new products or therapeutic innovations.
• Compliance & Regulatory Decisions
• Final sign-off on materials to ensure alignment with regulatory and ethical standards.
• Oversight of Patient Support Programmes (PSPs) to ensure legal compliance.
• Approval of responses to regulatory queries and updates to product documentation.
• Operational & Budgetary Decisions
• Allocation of medical budget and resources to support strategic priorities.
• Recommendations on portfolio development and commercial alignment.

Key Decisions (2/2)

• Strategic & Scientific Decisions
• Approval of medical content for promotional, educational, and training materials.
• Planning and endorsement of Continuing Medical Education (CME) activities.
• Scientific input into product positioning, lifecycle management, and launch strategies.
• Evaluation and recommendation of new products or therapeutic innovations.
• Compliance & Regulatory Decisions
• Final sign-off on materials to ensure alignment with regulatory and ethical standards.
• Oversight of Patient Support Programmes (PSPs) to ensure legal compliance.
• Approval of responses to regulatory queries and updates to product documentation.
• Operational & Budgetary Decisions
• Allocation of medical budget and resources to support strategic priorities.
• Recommendations on portfolio development and commercial alignment.

Education Qualification

• MBChB (Bachelor of Medicine and Bachelor of Surgery) - Preferred and commonly required.
• PhD or MPharm - Accepted with relevant experience.
• Postgraduate qualification in medicine, pharmacy, or healthcare management.

Registration with the Health Professions Council of South Africa (HPCSA) - Essential for medical professionals
Relevant Work Experience
I. 5-7 years of experience in the pharmaceutical industry or related healthcare sectors.
II. 2-3 years for candidates with an MD.
III. 7-8 years for candidates with a PhD or MPharm.
IV. Experience in managed care, medical insurance, or clinical research is highly valued
I. Scientific/Technical: Clinical data analysis, medical writing, regulatory affairs
II. Communication: Stakeholder engagement, training, clear scientific dialogue
III. Strategic/Business: Portfolio analysis, cross-functional teamwork
IV. Compliance/Ethics: Regulatory adherence, pharmacovigilance
V. Digital/Analytical: Data analysis, digital tool proficiency
VI. Personal Attributes: Independence, teamwork, adaptability

Skills Required