Medical Affairs Head Serbia & Montenegro
PharmaPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assuranceheormedicalgcppharmacovigilancehtacroinformaws
Job description
Job Description Summary The Medical Affairs Head for Serbia and Montenegro leads the local Medical Affairs function and is accountable for shaping and executing the medical strategy in line with global, regional, and local priorities. The role ensures scientific and medical excellence, drives launch readiness, evidence generation, clinical activities, patient access priorities, and compliant scientific engagement with healthcare stakeholders. Job Description Key Responsibilities: Medical strategy and execution Lead the Medical Affairs strategy for Serbia and Montenegro in alignment with global, regional, and local priorities. Translate scientific, clinical, access, and healthcare system insights into clear medical priorities and execution plans. Support launch preparedness, launch execution, reimbursement priorities, and patient access needs through medical input. Scientific excellence and evidence generation Ensure high standards of medical and scientific excellence across all Medical Affairs activities. Support evidence generation, real-world evidence, local studies, collaborative research, and clinical trial activities where applicable. Ensure accurate and timely communication of scientific and medical information to relevant stakeholders. External engagement Develop and maintain professional relationships with healthcare professionals, medical experts, investigators, patient associations, academic societies, institutions, regulators, and other relevant stakeholders. Lead scientific exchange, disease awareness, educational activities, advisory activities, and professional meetings in line with applicable policies and regulations. Represent Novartis at relevant scientific, clinical, and medical forums. Cross-functional partnership Act as the key medical partner to country and regional, Value and Access, Therapeutic Areas, Regulatory Affairs, Public Affairs, Compliance, Safety, Global Drug Development, and other relevant teams. Promote a collaborative ONE Team approach focused on patients, healthcare professionals, scientific credibility, and business impact. People leadership and resources Lead, develop, and retain a high-performing Medical Affairs team through recruitment, training, coaching, deployment, and capability building. Manage medical resources, budget, and priorities to support effective execution and operational excellence. Compliance, safety, and quality Ensure all Medical Affairs activities comply with applicable laws, regulations, industry codes, Novartis policies, Code of Conduct, pharmacovigilance, GxP, and quality requirements. Ensure timely and compliant reporting of adverse events, customer complaints, and product quality or safety incidents. Key Performance Indicators: Execution of the Serbia and Montenegro Medical Affairs strategy against agreed objectives and KPIs. Quality and impact of scientific engagement and external stakeholder partnerships. Aligned contribution to launch readiness, patient access, reimbursement, and clinical priorities. Compliance with legal, regulatory, safety, quality, and Novartis standards. Effective leadership, development, engagement, and retention of medical talent. Continuous improvement of Medical Affairs capabilities, processes, and operational efficiency. Required Background: Education Medical Doctor preferred. PharmD, PhD, or other relevant life sciences education may also be considered. Business or management education is an advantage. Experience Significant experience in Medical Affairs, clinical development, healthcare, life sciences, pharmaceutical industry, healthcare consulting, HTA, medical associations, or equivalent environment. Direct leadership experience (of 5+ people) and indirect leadership experience of similar scope in a matrix organization is required. X-functional experience (Commercial, Value and Access) is an advantage. Knowledge Strong understanding of pharmaceutical markets, healthcare systems, drug development, clinical trials, GCP, regulatory processes, pharmacovigilance, and ethical and legal requirements. Languages Fluent English required. Local language is preferred. Skills Strong medical leadership, stakeholder engagement, influencing, communication, business acumen, strategic thinking, collaboration, prioritization, analytical skills, resilience, and commitment to integrity and patient-focused decision-making. Location Serbia, on-site working. Skills Desired Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Medical Affairs, Patient Care, People Management, Pharmaceutics, Product Launches, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies, Results-Oriented, Stakeholder Engagement, Statistical Analysis
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