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Project Manager

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Seeking a Biotechnology/Diagnostics industry Project Manager to provide support in maintaining budgets, schedules, and addressing reporting needs for existing projects! This resource will provide project management support for new near-term projects and is a great long term contract opportunity.

Job Description:
1. 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.
2. 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.
3. 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.
4. Identifies potential project risks and develops contingency plans.
5. Develops and proposes to the LCT scenario plans to exploit new options and / or improve the existing plan.
6. Assist team members to develop detailed activity plans consistent with the key project milestones
7. Collates analysis and disseminates to the LCT of project management information and updates relevant documents and electronic systems.
8. Prepares and submits project documentation for the Lifecycle Committee via the LCT. 9. Leads LCT Sub-teams
10. 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.

Skills & Experience:
- 5 years experience in the diagnostics industry (IVD) with 3 years demonstrated successful cross functional project management experience
- Would prefer candidate from a Product Development background rather than an operations background
- Experience in medical device design, development, and manufacturing in an FDA regulated environment

Of particular interest is a working knowledge of:
- High-level coordination and planning of transfer to manufacturing and product launch activities for systems comprised of instruments and accompanying diagnostic tests

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

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