Senior Global Labeling Manager job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The DRA Senior Global Labeling Manager (Sr. GLM) is responsible for the development and maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned key development projects and marketed products throughout the product lifecycle to ensure accordance with Novartis policies and procedures. The DRA Sr. GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members, DRA sub-teams, and CPOs to ensure that the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with Novartis labeling processes and standards.|
Timely management of core labeling documents for the assigned products and brands. Ensure global internal compliance with Novartis Pharma PI Policy and adherence to regulatory internal policies and processes. Ensure timely and appropriate labeling for patient safety; minimize labeling related litigation/reputational risks worldwide by contributing to the avoidance of unjustified local deviations. Provide high quality global regulatory input for PSURs to ensure HA submission timelines are met. Performance is assessed based on contributions to key accomplishments noted in the Development objectives, feedback from internal customers, and evaluation made by DRA GL-TAL, DRA GL colleagues and Head of DRA-GL for the above listed Major Activities and the KPIs according to applicable SOPs.Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred Fluency in English as business language, additional languages advantageous. Special expertise and seniority in the listed activities. Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.