US-NJ, Global Labeling Therapeutic Area Lead 214130BR-MZ
Global Labeling Therapeutic Area Lead
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
The Global Labeling TA Lead (GL-TAL) drives and optimizes the strategy for the creation and maintenance of core labeling and critical regional/local labeling for high priority development programs and key marketed brands within the assigned therapeutic area(s). Working in close collaboration with GPRDs, GPTs, and DRA sub-teams, the GL-TAL leads/oversees the creation of core labeling documents (including DCDS, first CDS) and overseas/reviews the creation of key regional labeling (e.g. first USPI, EU SmPC) to ensure competitive, data-driven and regulatory compliant labeling. The GL-TAL leads discussions with global line functions to reach consensus on proposed labeling language and to assess the potential impact of critical regional/local labeling changes on core labeling. The GL-TAL serves as the primary interface between Global Labeling and the assigned BF/BU to ensure alignment on priorities and GL resourcing for labeling activities in the assigned therapeutic area(s). The GL-TAL supervises and/or mentors regulatory global labeling managers, GLM(s), and liaises with other GL-TALs or Hyderabad GL Team Leads to ensure extended resourcing as needed to achieve business objectives.
Regulatory Labeling Strategy: Provide strategic regulatory labeling guidance/leadership on key projects/products within their designated Therapeutic Areas. Support labeling issue management. Drive the strategic optimization of critical labeling documents via close scrutiny of company data, regulatory precedents and trends, and competitor labeling. Ensure that key regional/CPO input is sought and incorporated into global regulatory labeling strategy. Ensure contribution to DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for key development and marketed products. Ensure contribution to the overall liability risk management strategy for Novartis Pharma by representing GL on Risk Communication Task Force (RCTF) teams, providing input on RMS/REMS, and reviewing inter- divisional and cross-company pharmacovigilance agreements to enhance global alignment with the company s position on the product s safety profile. Provide leadership on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices. Contribute as a core member of Global DRA Sub teams, and Safety Management Teams (SMTs) and work in close collaboration with the GPRD and relevant line function expert(s) on creation/maintenance of core labeling. May update Global Program Teams (GPTs)/Global Brand Teams (GBTs) on an ad-hoc/issue-driven basis for assigned projects/products.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred. Fluency in English - written and spoken. Additional language is an asset. At least 6-8 years experience 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. Solid understanding of drug development and pharmaceutical product liability. Advanced interpersonal skills. Strong conflict management skills. Open communicator. Excellent verbal and written communication skills. Innovation in regulatory labeling strategy. Proven ability to analyze and interpret efficacy and safety data. Demonstrated ability to manage and develop associates. High level of organizational awareness.
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