R&D Project Manager

Research & Development Carmel, New York


Description

The Project Manager is responsible for product lifecycle management. Projects will range from early development through commercialization and post-approval changes. Projects will involve both internal and external resources. The Project Manager will lead cross-functional teams in preparing project timelines, scope, deliverables, communication plans and budgets to ensure milestones are met and projects are completed on time. The Project Manager coordinates the resources required for successful project completion, identifies and removes roadblocks, and maintains project tracking tools in order to provide up-to-date project status as required.

 

Note:  This position is primarily based in the Carmel NY site with travel between sites as needed.  Minimum onsite requirement of 3-5 days per week in site based facility.

 

Responsibilities

 

  • Work with project stakeholders to initiate new projects, set timelines, coordinate meetings, identify and help to resolve obstacles, and escalate issues when necessary to support resource allocation and on-time project completion
  • Develop, manage and communicate project plans and other company tracking tools
  • Continuously evaluate the product portfolio in order to ensure proper prioritization
  • Communicate project objectives, deliverables, timelines and tasks to team members
  • Manage the deficiency tracking system and gap analysis program to ensure that action items are completed on time to support timely approvals
  • Work with the appropriate department head to develop project budgets, scope of work and risk assessments as part of the lifecycle management process
  • Review product proposals from contract organizations and act as the primary contact for defined projects; act as liaison between internal resources and vendors
  • Demonstrate leadership qualities while facilitating team meetings to ensure the agenda is followed; coordinate follow-up on action items
  • Promote continuous improvement of key business processes, including training other functional areas in project management processes and activities as necessary
  • Creating purchase requisitions and ordering project supplies such as RLDs
  • Assist with planning for DEA quotas and permits as applicable
  • Other duties and responsibilities as assigned

 

Qualifications

 

  • Bachelor's degree in scientific discipline or related field required
  • Advanced degree in science or management a plus
  • Minimum of 3 years of project management experience in the pharmaceutical industry, generic preferred
  • PMP certification preferred but not required
  • Working knowledge of product development and related industry guidelines, such as ICH and GMP
  • Understanding of FDA regulatory development and submission processes
  • Proficiency with MS Office Programs, including MS Project
  • Proven ability to manage multiple, multi-faceted projects and deliver results
  • Experience working with multidisciplinary groups (internal & external) and ability to work in and  communicate across all levels of the organization
  • Leadership, negotiation, presentation and facilitation skills
  • Ability to work with minimal supervision to meet required timelines

Accountabilities

 

  • Complying with established company policies and procedures
  • Functioning in a professional manner and maintaining a high level of business and professional ethics
  • Monitoring and controlling project budgets
  • Ensuring adherence to established timelines
  • Identifying and resolving any problems or potential problems that might delay, or otherwise negatively affect project schedules and/or results
  • Ensuring product submissions are prepared and submitted according to schedule