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Job Position: Senior IT Project Manager – Healthcare/ERP/PLM
Location: NJ or MI
Duration: Long term
Key Activities & Accountabilities:
· The Project Manager is responsible for supporting the current Regulatory Systems (Sparta TrackWise) within the UDI project to facilitate the design, software validation, implementation, and support of the technology solutions to ensure the client can comply with the new federal UDI legislation.
· Leads project meetings with Business Analyst, Business users, and SME to assure project is on schedule and that all risks are communicated to appropriate teams and management.
· Identify gaps between teams with established requirements and process and resolve or communicate all gaps between teams in a timely manner.
· Assure the development of all necessary system documentation and validations documents are completed in collaboration with the Business Analyst, validation team, and IT Quality.
· Reporting on timeline, deliverables, Issues, Risks
· Status Reports Ensure the Project delivers within the FDA required timeline to ensure compliance with new regulations.
· Proficient with Microsoft Project.
Expected Qualifications:
· BS or BA degree or equivalent
· 6+ years of experience in a Project Manager role; driving collaboration across IT and key business stakeholders
· 4+ years' experience designing and implementing complex business solutions
· Project Management Professional (PMP) a plus
· Previous experience in regulated environments, i.e. Pharmaceuticals, Medical Device
· Knowledge of various Enterprise systems and applications including but not limited to Sparta Trackwise, ERP (Oracle, JDE) PLM (Agile, PTC)
· Experience in large scale IT program implementation; design, implementing, deployment and validation enterprise software system compliant in an FDA environment.
· Ability to develop strong relationships with stakeholders and customers
· Strong communication and listening skills, problem solving and team leadership skills. Ability to accept and process customer feedback.
· Strong customer service orientation
· Works as a collaborative part of the program team in a fast-paced and ever changing environment
· Exceptional written, verbal and presentation skills to a diverse set of audiences
· Excellent planning, organizational, and problem solving skills.
· Ability to work under time constraints to meet deadlines
· Ability to manage and prioritize workloads
· Ability to successfully execute Project management methodologies, tools and skills.
· Utilizes proper software and technological tools to maintain proper records including and not limited to Visio, Excel, Word, SharePoint, and PowerPoint.
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Regards..
Srinivas Madala
Executive – Talent Management
499 Thornall Street, 3rd Floor, Edison, NJ 08837 | Direct: 732.404.8365|Fax: 732.875.0770 | Visit us at: www.techdemocracy.com
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