Apr 13, 2022

Job Description

1.5 million patient kits are packed in Global Clinical Supply! The GCS Business Process Manager (BPM) is responsible for process excellence and process evolution (in line with the overarching GCS strategy) within the respective GCS unit by acting as the process owner for internal Packaging Operations (covering planning, production master data set-up, primary and secondary packaging, warehousing) and supporting the GCS long term strategy.

The RA Global Labeling Therapeutic Area Lead (GL-TAL) is a leadership position in RA Global Labeling accountable for driving and optimizing the strategy for the creation and maintenance of core labeling and regional/local labeling for development programs and marketed brands.
May also have full responsibility for one or more high complexity brands or development programs.
The GL-TAL serves as the primary interface between Global Labeling and the assigned DU(s) to ensure alignment on priorities and GL resourcing for labeling activities in the assigned therapeutic area(s).
Through effective leadership, develops the functional competencies of associates within the team and works with GL Leadership to ensure resources as needed to achieve business objectives.

Major Accountabilities
• Manage RA GLM(s), support high quality GL contributions, support label issue management and provide strategic advice
• Manage performance (set objectives, support development, review and evaluate performance, talent review and plan compensation).
• Facilitate GL resource allocation to align with GL and DU priorities.
• Represent GL in monthly Development Unit stakeholder meetings or other meetings as appropriate. Provide strategic regulatory labeling guidance/leadership on key projects/products within designated Therapeutic Areas (TAs). Support labeling issue management.
• Ensure timely, clear communications on project/issues/risks on labeling matters with teams, RA GL LT, and key stakeholders internally, and/or with HAs, as appropriate.
• Ensure labeling deliverables for assigned therapeutic area(s). Ensure optimal resource utilization for assigned activities.
• Create and maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
• Fluency in English as business language (excellent written and oral), additional languages advantageous.
• Extensive experience (at least 6-8 years) in global labeling or other global regulatory affairs functions with a strong focus on labeling.
• 2-5 years demonstrated leadership and accomplishment in a global/matrix environment in the pharmaceutical industry.
• Strong understanding of drug development and pharmaceutical product liability.
• Innovation in regulatory labeling strategy. Proven ability to analyze and interpret efficacy and safety data.
• Advanced interpersonal project management, communication, negotiation and problem-solving skills. Strong conflict management skills. Open communicator.
• Excellent verbal and written communication skills.
• Demonstrated ability to manage and develop associates.
• High level of organizational awareness and strong quality and customer focus.

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Imagine what you could do here at Novartis!

Global Drug Development
Research & Development
Full Time
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Global Labeling Therapeutic Area Lead

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