Overview
Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism) located London. 12 days on site if within 50 miles of the London office, otherwise remote. Contribute to global labelling strategies across the product portfolio.
Responsibilities
* Develop and maintain global labelling strategies and documents (e.g., CDS, USPI, EU SmPC/PIL).
* Lead cross‑functional discussions to align on labelling content and strategy.
* Present labelling proposals and updates to governance bodies and project teams.
* Identify emerging labelling considerations, contributing to planning, risk assessment, and mitigation strategies.
* Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.
* Support responses to Health Authority queries and interactions, including preparation of supporting documentation.
* Collaborate with global and regional partners to ensure consistency and alignment across markets.
* Mentor colleagues and support audit readiness, inspections, and continuous improvement initiatives.
Qualifications
* Fluency in English (written and spoken).
* Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, focused on labelling across development and lifecycle activities.
* Ability to develop and maintain core labelling documents (e.g., CDS) and support major market labelling with scientific accuracy and compliance.
* Ability to interpret clinical efficacy and safety data and translate into clear, consistent labelling content and supporting documentation.
* Working knowledge of global labelling standards and expectations, including major Health Authority requirements.
* Strong collaboration and communication skills, facilitating cross‑functional discussions and supporting alignment.
* Strong planning, prioritisation, and attention to detail to deliver high‑quality work within timelines.
EEO / Diversity
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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