NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
- Act with integrity in everything we do.
- Provide best-in-class customer experiences.
- Develop superior talent and deliver expertise.
- Respond with agility and provide timely results.
- Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Partner with the client , cross-functional team and sub-contractors to effectively staff and manage project execution throughout the entire project life cycle• Serve as key liaison with client, including communications in critical and high-profile discussions
• Resolve or de-escalate challenging situations with the client, and know when to escalate issues to management
• Ensure a balance of both the client and NAMSA business needs
• Facilitate up-front client engagement to establish project scope, deliverables, timeline, client requirements for communication, invoicing etc. and ensures client expectations are met for quality, schedule and budget
• Facilitate project handoff from commercial to operations with signed SOW
• Facilitate accurate and timely project set-up and team access in applicable systems, including SharePoint, AX, and project specific systems.
• Lead project planning of deliverables, schedule, budget, resources, communications, organize and facilitate meetings, scope metrics , outline workplan, identify and assign roles & responsibilities and risk management.
• Manage financial aspects of the projects according to the statement of work and facilitate change orders as needed.
• Lead project closure with client acceptance and survey, documentation and system closure
• Gather and take action on lessons learned as applicable. Provide timely feedback on team members using the appropriate performance management processes.
• Utilize NAMSA project management best practices and tools, and drive improvements in capability, utilization, and cycle time.
• Support simple single service projects with minimal cross-functional interaction or supports senior project managers with complex projects.
• Work under general supervision and follows established procedures with some latitude in decision making and approach to responsibilities.
• Ensure projects are executed following QS requirements and applicable procedures
• Maintain project metrics and reporting for management reviews.
• Support client and regulatory audits and follow-up
• Ensure any complaints are filed including the support of CAPAs or quality initiatives as needed for quality and process improvement.
• Participate in prospective and current client meetings and identify opportunities to offer additional services for clients during engagements
• Provide project schedule, resource, and budget information as needed to support creation of proposals.
• Other duties as assigned
• Performs other duties as assigned.
Qualifications & Technical Competencies:
• Bachelor’s degree in a related field required or equivalent
• MBA or Advance degree preferred
• Minimum of 3 years of experience in medical device, clinical, regulatory or related field required
• At least 1 year Project Management experience required
• Demonstrated execution of project management tools, processes, practices and procedures
• Advanced Certification in a relevant program such as project management, clinical research, six sigma, lean, or similar program preferred
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) preferred
• Proficient with MS Project or similar and SharePoint
• Ability to understand and navigate the complexity of multiple moving activities, competing priorities, and limited resources
• Ability to persuasively influence client and internal stakeholders to ensure high quality deliverables are completed on time and budget
• Strong verbal and written communications skills, with the ability to motivate, influence, and negotiate
• Excellent time management, organization, and project management skills
• Effective analytical and problem solving capabilities, with the ability to translate complex problems to be easily understandable
• Understanding of project financials and impact to the business
• Understanding of technical project components and impact on other technical project areas
• Ability to work in a highly matrixed team environment
• Ability to train and mentor others.
• Partner with the client , cross-functional team and sub-contractors to effectively staff and manage project execution throughout the entire project life cycle
• Serve as key liaison with client, including communications in critical and high-profile discussions
• Resolve or de-escalate challenging situations with the client, and know when to escalate issues to management
• Ensure a balance of both the client and NAMSA business needs
• Facilitate up-front client engagement to establish project scope, deliverables, timeline, client requirements for communication, invoicing etc. and ensures client expectations are met for quality, schedule and budget
• Facilitate project handoff from commercial to operations with signed SOW
• Facilitate accurate and timely project set-up and team access in applicable systems, including SharePoint, AX, and project specific systems.
• Lead project planning of deliverables, schedule, budget, resources, communications, organize and facilitate meetings, scope metrics , outline workplan, identify and assign roles & responsibilities and risk management.
• Manage financial aspects of the projects according to the statement of work and facilitate change orders as needed.
• Lead project closure with client acceptance and survey, documentation and system closure
• Gather and take action on lessons learned as applicable. Provide timely feedback on team members using the appropriate performance management processes.
• Utilize NAMSA project management best practices and tools, and drive improvements in capability, utilization, and cycle time.
• Support simple single service projects with minimal cross-functional interaction or supports senior project managers with complex projects.
• Work under general supervision and follows established procedures with some latitude in decision making and approach to responsibilities.
• Ensure projects are executed following QS requirements and applicable procedures
• Maintain project metrics and reporting for management reviews.
• Support client and regulatory audits and follow-up
• Ensure any complaints are filed including the support of CAPAs or quality initiatives as needed for quality and process improvement.
• Participate in prospective and current client meetings and identify opportunities to offer additional services for clients during engagements
• Provide project schedule, resource, and budget information as needed to support creation of proposals.
• Other duties as assigned
• Performs other duties as assigned.
