Project Leader II - Clinical Development Job

Organization
GE Healthcare
Job Location
Marlborough, MA
Job Description

The Project Leader II is responsible for driving cross functional New Product Introduction project execution for a product. The project Leader II develops the Integrated Project Plan and leads the team to successfully deliver the project team objectives. He/she ensures that the necessary resources are applied and delivering to plan. In addition the Project Leader II works with a cross-functional team to ensure product manufacturability, serviceability, safety and quality. 
Essential Responsibilities: 
- Leading and managing multiple projects within the Core Imaging R&D portfolio to agreed specifications and quality within the approved budget and resources. 

- Working closely with all cross-functional groups in delivering the project(s). 

- Leading cross-functional project activities. 

- Working with the line functions to ensure full compliance with all applicable laws, legislation and regulatory requirements e.g. GLP, GMP and GCP 

- Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives 

- Forecast and track resources and materials for timely NPI project execution 

- Work with core team members to complete monthly reports (financial & status) 

- Define core team, scope & functional deliverables. Work with the cross functional team to generate project dashboard (objectives) & review status with team and sponsor 

- Hold biweekly project team meetings, issue agendas and actions/decisions. Maintain action/decisions log and other project related documentation (project charter, scope, timelines, etc) in team library. 

- Maintain accurate budget & timeline information (cost, time & quality) including best & base case scenarios. 

NEHPP

Requirements: 

Qualifications/Requirements: 1. BS/MS Degree in Life Sciences, Chemistry, Physics 

2. Minimum of 5 years project leadership experience pharmaceutical and/or clinical development 

3. Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion 

4. Familiarity with FDA/EMEA/PMDA/CFDA and other regulatory standards and guidelines 

5. Demonstrated understanding/experience with the New Product Introduction (NPI) cycle 
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. 
Desired Characteristics: 1. PhD Degree in Life Sciences, Chemistry, Physics, 
2. Strong written and verbal communication skills 
3. Experience with conflict resolution 
4. Self-starter, energizing, results oriented, and able to multi-task 
5. Demonstrated problem solving ability and results orientation. Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues 
6. Demonstrated ability to work in a collaborative, matrixed, and customer focused environment 
7. Excellent communication, influencing skills and ability to gain buy-in for initiatives 
8. Project management certification 
9. Demonstrated skills in proactively identifying, facilitating and driving closure of a product 
10. Knowledge of GE Healthcare engineering tools and processes 
11. Attention to detail and ability work independently toward timely completion of a variety of assignments 
12. Ability to develop unique concepts/solutions for complex products

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