At a Glance
- Tasks: Lead global labelling strategies for innovative cardiovascular, renal, and metabolism products.
- Company: Join Novartis, a leader in healthcare with a commitment to diversity and inclusion.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with mentorship opportunities and focus on continuous improvement.
- Why this job: Make a real impact on global health by ensuring clear and compliant product information.
- Qualifications: Experience in global labelling or regulatory affairs with strong communication skills.
The predicted salary is between 80000 - 100000 Β£ per year.
Job Description Summary
- #LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)
- #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 (Cardiovascular, Renal & Metabolism) 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.
- Major Accountabilities
- Develop and maintain global labelling strategies and core labelling documents for assigned products (e. g. CDS, USPI, EU Sm PC/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.
- 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 Sm PC/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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#J-18808-Ljbffr