The Client’s Marlborough site is engaged in medical device design and development. Project teams at this site are interfacing with teams for projects:
(a) involving clinical trial validation studies, regulatory submissions, and launch activities as well as
(b) projects involving instrument design, development and transfer.
An experienced individual with general project management expertise is needed at the Marlborough site to coordinate planning and activities involving all three sites.
• Leads in the creation of the Life Cycle Team (LCT) project plan, ensuring that the plan is aligned with the approved development goals and appropriately balances time, quality and costs. Takes accountability for and ownership of the project plan. Regularly monitors and updates the plan to ensure up-to-date information is available.
• Tracks progress of key project tasks and milestones / activities and develop corrective-action in case of deviation. Ensures that content and timing of inter-departmental deliverables is clear to those involved. (Top level project timeline.) Also ensures that necessary decisions are reached in a timely fashion and based on the clear business goal of the project. Works with project managers to resolve inter-project conflicts.
• Regularly performs a cost-exception analysis; identifies factors driving changes in forecast. Develops and in some cases implements corrective-action. Challenges assumptions regarding time, cost and quality matters.
• Identifies potential project risks and develops contingency plans.
• Develops and proposes to the LCT scenario plans to exploit new options and / or improve the existing plan.
• Assist team members to develop detailed activity plans consistent with the key project milestones
• Collates analysis and disseminates to the LCT of project management information and updates relevant documents and electronic systems.
• Prepares and submits project documentation for the Lifecycle Committee via the LCT.
• Leads LCT Sub-teams
• Guides and manages and tracks the creation of project documentation according to Design Control Guidelines as well as preparation and conduction of project milestone reviews.
Experience in medical device design, development, and manufacturing in an FDA regulated environment (5 years with 3 years demonstrated successful cross functional project management experience) of particular interest is a working knowledge of:
• Coordination and planning of instrument design, development, and transfer to manufacturing (30% time)
• Coordination and planning of clinical trial, regulatory affairs, and product launch activities (70% time)
Some Research and Development experience
General project management skills including a working knowledge of:
• MS Project, MS Excel, One–Pager Pro and similar project management tools
• Development and management of project plans, timelines and milestone tracking
• Resource and PVC planning; development and management of project budgets
• Risk management
• Mature communication and people skills
• Working with global teams across multiple sites
Location: Marlborough, MA.
Contact: Venkata Giri
The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at /firstname.lastname@example.org\ for review before we speak.