The opportunity
Key drivers of our growth in US Generics are the launches that come from our in-house development and 3rd party partners. As an Associate Director, New Product Strategy your challenge is to manage the generic new product projects in a close relationship with the market. You have a central role in which you coordinate the process from ANDA submission through to launch. It’s a position with many local and global interfaces and a responsibility that significantly impacts our business.
The Associate Director, New Product Strategy will manage the strategic and tactical execution of new product strategy and planning from the time the file is submitted to the FDA to the point of product launch. You will also collaborate with R&D during development to provide commercial input and identify risks to launch strategy. The job incumbent will monitor the product through major capital investments, litigation, regulatory interfaces and pre-launch/validation/launch activities. Working in coordination with key stakeholders in Generic R&D, Operations, Legal Affairs, Regulatory Affairs, Quality Management, Supply Chain, Global Purchasing, Business Development and Sales & Marketing; the Associate Director will ensure on time launch of new products within Teva USA. The incumbent will assist in the development of the launch strategy, identify risks, monitor issue resolution, and manage key project milestones as part of the coordinated effort. He/she must raise red flags if milestones are not reached or when financial terms require re-evaluation of the launch strategy.
How you’ll spend your day
Lead the development of new product plans including all activities from the time of FDA submission to product launch.
Report progress on execution of the plans, identify risks, highlight issues in conjunction with recommended solutions and seek input/approval from the management team for plan changes as required.
Collect and assimilate information regarding future new products from pertinent inside resources and functional areas as well as outside information resources.
Develop, with the appropriate functional areas, the launch strategy for each new product including: characterization / scale-up, validation and launch plans, financial analysis, and regulatory/legal/process impacts and risks. Communicate this strategy to the appropriate personnel involved in the launches.
Work with stakeholders to define major milestones and report / resolve issues with meeting these dates. Establish accountability and drive target completion of all major milestones associated with each individual new product launch project.
Provides guidance and direction to R&D and operations site project managers during all phases of the new product development and commercialization that impact launch strategy.
Work to ensure the successful and timely execution of new product launch plans. This is achieved through tight coordination with sales, marketing, supply chain, manufacturing, distribution, regulatory, quality and legal affairs.
Manage changes in scope based on changing strategic direction and properly/ timely communicate changes.
This is a hybrid role requiring the selected candidate to work onsite in Parsippany 3 days per week.
