Job Description
Purpose:
The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM). The SPML will be responsible for leading global, cross-functional submission teams to meet or exceed the operational delivery goals for JJIM's major submissions in EU and U.S. markets and is the primary interface to JJIM's Compound Development Team (CDT) regarding operational submission strategy. The SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and Project Management Leader (PML) in driving the timely delivery of major NDA/BLA/MAA submissions.
This Individual Will Work Across Teams At All Levels Of
The Organization To Ensure
The Highest Probability Of Successful Submission Delivery While Enhancing Team Empowerment, Effectiveness, And Efficiency In Accordance With
The Johnson & Johnson Credo. This Includes
Key Responsibilities Close partnership with the CDT, Therapeutic Area (TA) and Functional Leadership, working hand in hand with the GRL to facilitate alignment, clarity, understanding and endorsement of the overall submission strategy or submission "North Star"" based on bolthires label and overall global regulatory strategy.