Title: PROJECT MANAGEMENT SPECIALIST SOFTWARE DEVELOPMENT LEAD
Location: Tarrytown, NY
Duration: 6 Months (With possible conversion to fulltime)
Note from Manager:
**This position will focus in leading Software Development Projects in the Complaint Database System therefore the Project Management Specialist needs to have a strong experience in leading such projects. Experience with Complaint Databases desirable. Knowledge of SAS and Qlik View and user interactive tools highly desirable.
Project Management Specialist – Software Development Lead is responsible for facilitating the effective and efficient execution of all assigned Quality Compliance project activities.
The Project Management Specialist is responsible for supporting teams in the planning, scheduling, tracking, coordination, monitoring, and successful completion of Regulatory projects to fully comply with Food and Drug Administration (FDA) regulations and all applicable other external regulations and laws.
This position will focus in leading Software Development Projects in the Complaint Database System therefore the Project Management Specialist needs to have a strong experience in leading such projects.
Responsible for execution of complex project/program plan.
Responsible for delivery of complex project/program.
Performs project/program management activities (defining scheduling, budget, risk, change, opportunity and resource management activities).
Performs technical review of system design and documentation.
Executes continuous improvement plan.
May perform active role in maintaining client relationship.
• Track project performance, specifically to analyze the successful completion of short- and long-term goals
• Performs project/program management activities (defining scheduling, risk, change and opportunity and resources activities).
• Responsible for Project Schedule compliance.
• Participates in technical review of Project related processes and documentation.
• Independently performs important areas of standard professional level work that typically requires processing and interpreting more complex, less clearly-defined issues.
• Schedules and may lead meetings to coordinate cross functional project activities required to resolve project issues.
• Supports project communications to all stakeholders including meeting minutes, monthly updates and other communications.
• Monitor status of each Software Development deliverable; follow up effectively on each deliverable to ensure compliance to schedule and applicable procedures and regulations.
• Supports and participates in external partners relationships where required.
• Create tools to manage efficiently assigned Projects.
• Successfully lead in delivering Software tools that fully support management reporting, data summaries and charts, identification, trending, reporting requirements and other critical attributes.
• Write professional reports and presentations for reporting to management.
• Ensure documents are complete and in compliance with Clients procedures and regulatory requirements.
• Responsible to collaborate effectively with other functions.
• Experience in successful deployment and use of Project Management skills.
• Strong experience in leading Software Development Projects.
• Ability to work and influence in a matrixed organization is essential.
• Knowledge of FDA Medical Device Regulations (i.e. Complaint Files Quality System Regulation QSR 820.198) and other worldwide laws and regulations.
• Expertise and ability to use a variety of electronic (IT) systems to facilitate efficient project management.
• Requires skills in the in the medical device industry (FDA 820, 803, 806) or pharma. Knowledge and experience in the Diagnostics Medical Devices industry highly desirable (Complaints etc.).
• Experience with documenting Quality and Regulatory Reports.
• Experience with Complaint Databases desirable.
• Knowledge of SAS and Qlik View and user interactive tools highly desirable.
• Basic knowledge in Software Validation desirable.
• Experience with Data Analysis using Excel and other tools
• Experience with other Microsoft programs (Word, Power Point, Visio) and expertise in Microsoft Project and time management tools.
• Ability to communicate well complex information and data to others.
• Excellent English writing and communication skills.
• Experience in updating Quality procedures desirable.
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
5-7 years of experience
Excellent Technical writing, communication and organizational skills necessary.
Key Working Relationships: Primarily intra organizational contacts and external contacts