Description:

The Senior Manager, Project Management is responsible for managing the various project components with all parties involved and to inform the stakeholders of progress, intermediate results, potential problems and suggested corrective actions.

Essential Functions:

• Build strong relationships with cross-functional and multi-disciplinary functional stakeholders to drive various project requirements in an efficient manner. Must have the capability to build strong team dynamics of diverse individuals representing the various functions as part of product development.

• Lead and manage all activities related to product development through the entire product cycle from strategic and tactical perspectives. Have the ability to define clear project scopes, goals and deliverables that support business objectives.

• Possess a deep understanding of the technical details underlying product development to effectively strategize, plan and co-ordinate project activities with the functional stakeholders and senior management. Need to have the ability to provide an independent opinion on all project activities and to be counted as part of the decision making group.

• Lead and develop an independent function to effectively communicate project expectations and timelines, proactively anticipate project related issues and devise contingency plans.

• Develop and implement an efficient process for managing all of the tactical aspects of product development to include managing weekly R&D meetings, maintain accurate timelines of internal and external events related to the projects, provide weekly/monthly update documents, proposals and presentations.

• Participate and provide input into developing and maintaining ongoing project expenses and annual budgets.

• Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program.

Additional Responsibilities:

• Mentor direct reports and other PMs in the group.

• Lead multi-site project initiatives as directed.

Qualifications - External

Education:

• Master Degree (MS/MA): pharmaceutical sciences - Required

• Master Degree (MBA): Preferred

• Ph. D.: Preferred

Experience:

• 5 years or more in understanding of the generic pharmaceutical development process experience in at least one of the following areas: drug formulation development, clinical strategy development, project management is required.

Skills:

• Demonstrates ability to manage teams and possess strong interpersonal, oral and written communication skills.

Specialized Knowledge:

• Understanding of the Regulatory process and Intellectual Property issues as it pertains to ANDA filings.