Resumé
About the Role
Major Accountabilities
Medical Strategy & Scientific Leadership
- Contribute to the design, execution, and monitoring of the local Medical Affairs plan in alignment with global and regional medical strategies.
- Act as a scientific reference for the assigned Therapy Area, ensuring medical activities are patient‑centric, evidence‑based, and non‑promotional.
Scientific Exchange & Stakeholder Engagement
- Establish and maintain high‑quality scientific dialogue with Key Opinion Leaders (KOLs), investigators, scientific societies, and relevant regulatory or public health stakeholders.
- Support scientific meetings, advisory boards, and educational initiatives in compliance with internal governance and external regulations.
- Medical Information & Scientific Accuracy : Ensure timely, accurate, and high‑quality responses to medical inquiries in accordance with applicable standards and SOPs.
Clinical Research & Evidence Generation
- Provide medical and scientific input into the planning, initiation, execution, and oversight of clinical research activities, including:
- Non‑Interventional Studies (NIS)
- Investigator‑Initiated Trials (IITs)
- Real‑World Evidence (RWE) initiatives
- Support country evidence generation strategy in alignment with global guidance and local priorities.
Cross‑Functional Collaboration & Insights
- Provide medical insights to cross‑functional stakeholders including Pharmacovigilance, Regulatory Affairs, Market Access, Quality, Commercial, and Brand teams.
- Ensure systematic collection, documentation, and communication of medical insights to inform strategy and decision‑making.
Medical Governance & Compliance
- Coordinate medical review and approval of locally developed and global medical materials in accordance with Medical Governance, and local SOPs.
- Ensure clear separation between promotional and non‑promotional activities.
- Identify, assess, and mitigate medical and compliance risks within the scope of responsibility, ensuring appropriate internal controls are implemented and monitored.
Patient Safety & Quality
- Ensure reporting of adverse events, technical complaints, and special case scenarios within 24 hours, in line with Pharmacovigilance requirements.
- Support quality and safety culture across all medical activities.
Key Performance Indicators (KPIs)
- Compliance with Ethics, Compliance, Medical Governance, and SOP requirements.
- Quality and scientific rigor of medical activities and deliverables.
- Effective contribution to medical strategy execution and evidence generation.
- Timely and accurate medical information responses.
- Quality of cross‑functional collaboration and medical insights shared.
Minimum Requirements
Education & Experience
- Medical, pharmacy (preferred) or life‑science degree (MD, PharmD, PhD or equivalent).
- Experience in Medical Affairs, Clinical Research, or related scientific roles within the pharmaceutical or healthcare environment.
- Demonstrated experience in cross‑functional collaboration and project execution.
Core Competencies & Skills
- Medical & scientific expertise in the assigned Therapy Area.
- Clinical research and evidence generation knowledge.
- Strong understanding of Medical Affairs governance, compliance, and pharmacovigilance.
- Strategic thinking and analytical skills.
- Excellent communication and stakeholder engagement capabilities.
- Project management and organizational skills.
Languages
- English, French (fluent)
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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