Novartis
GlobalLabellingAssociateDirector,Content
“Global Labelling Associate Director, Content at Novartis. Skills: Global Labelling, Global Regulatory Affairs, labelling strategies, content development. Develop and maintain global labelling strategies and core labelling documents for assigned products (e. g. CDS, USPI, EU SmPC/PIL). Identify emerging labelling considerations and contribute to planning, risk assessment, and mitigation strategies”
What You'll Achieve.
enable compliant and competitive product information for global markets
Industry & Context.
risk assessment; mitigation strategies
What They're Looking For.
Must Have
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, collaboration and communication skills, with the ability to facilitate cross-functional discussions and support alignment, planning, prioritisation, and attention to detail to deliver high-quality work within timelines
What You'll Do.
Develop and maintain global labelling strategies and core labelling documents for assigned products (e. g. CDS
Identify emerging labelling considerations and contribute to planning
and mitigation strategies
Analyse competitor labelling
and scientific data to inform content development
Support and contribute to responses to Health Authority queries and interactions
including preparation of supporting documentation
How You'll Work.
Team & Collaboration
Lead and facilitate cross-functional discussions to support alignment on labelling content and strategy; Collaborate with global and regional partners to ensure consistency and alignment across markets
Communication Scope
communication skills; facilitate cross-functional discussions
Process & Methodology
planning, prioritisation
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