Summary
#LI-Remote (Homeworker if living further than 50 miles of our London office)
Office Location: London (The Westworks), United Kingdom
We are looking for a Global Labelling Associate Director, Content to contribute to the development and delivery of global labelling strategies across a portfolio of products.
In this role, you will support the creation of clear, consistent, and scientifically robust labelling content across development and lifecycle stages. You will work closely with cross-functional partners to ensure alignment on labelling strategy, enabling compliant and competitive product information for global markets.
About the Role
Major Accountabilities
- Develop and maintain global labelling strategies and core labelling documents for assigned products (e.g. CDS, USPI, EU SmPC/PIL).
- Lead and facilitate cross-functional discussions to support alignment on labelling content and strategy.
- Present labelling proposals and updates to governance bodies and project teams
- Identify emerging labelling considerations and contribute to planning, risk assessment, and mitigation strategies.
- Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.
- Support and contribute to 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 contribute to audit readiness, inspections, and continuous improvement initiatives.
Essential Requirements
- Fluency in English (written and spoken).
- Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, with a focus on labelling across development and lifecycle activities.
- Ability to develop and maintain core labelling documents (e.g. CDS) and support major market labelling (e.g. USPI, EU SmPC/PIL) with scientific accuracy and compliance.
- Ability to interpret clinical efficacy and safety data and translate it 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, with the ability to facilitate cross-functional discussions and support alignment.
- Strong planning, prioritisation, and attention to detail to deliver high-quality work within timelines.
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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