About Abbott At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in diagnostics, medical devices, nutrition and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
About Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. Infectious Disease is a billion-dollar business unit within Abbott Rapid Diagnostics.
12-month FTC
Purpose of the Job The position of NPI Program Manager – IVDR is within our Infectious Disease Project Management Office, located in Galway, Ireland. This is a critical role in the ongoing management of new project initiation + transition from Phase 0 to NPI. The NPI Program Manager – IVDR will report directly to the Director Project Management in Galway.
Responsibilities and Duties Manages all activities for new project initiation + transition from Phase 0 to NPI, bringing projects through to major regulatory submission & approvals, including CE IVDR, by acting as the global leader for cross-functional Phase 0 + NPI project teams:Works cross-functionally with teams such as Global Strategic Marketing, Market Access, Research & Development, Human Factors, Medical Clinical & Scientific Office, Quality, Regulatory, Operations, Procurement, Component Engineering, Supply Chain, Product Stewardship, Commercial, Finance.Guides teams through Phase 0 by helping them to formulate the project charter & target product profile (TPP) by building interdependent programme elements such as the business case, technical readiness assessments, functional strategies, risk & mitigation plans, high level directional timelines, resource requirements, project costs, return on investment, COGS assessments. Listens for assumptions & challenges them to help the team articulate their thinking & build robust assessments into Phase 0 programme elements. Gains team alignment on messaging & presenting to leadership for feedback & using same to continuously improve & shape the project charter & TPP as the project progresses through Phase 0.Brings Phase 0 projects that meet Phase 0 exit requirements to a formal Phase Gate review where team presents readiness to move to NPI. Gain leadership team approval of same & formally move to NPI.Translates Phase 0 outputs into more detailed program/project plans, including built-out timelines with interdependent tasks aligned with Phase Gate + Design Control Deliverables, budgets, resource requirements, risk & mitigation plans. Gains cross functional team collaboration & alignment while developing such plans. Works with team to obtain leadership review & approval.Once approved, executes the plans with the team. Maintains updated scorecards, timelines, decision tracker, risk register, meeting agendas, minutes + actions etc. Routinely hosts cross functional technical core team meetings to assess progress and to drive critical & shadow chain deliverables forward as scheduled.Proactively identifies & addresses assumptions & risks before they are realised by managing workstreams as needed to drive collaboration & problem solving, escalating where support is needed to reach solutions. Identifies when team members need help & gets support in place as needed.Aligns with team on updates for monthly project reviews, ensuring the right things are escalated to help get leadership direction & decisions so that project can progress on time & within budget. Helps team prepare and execute Phase Gate Reviews.Ensures compliance to Abbott Quality requirements such as Design Control, QMS & Document Control.Drives a good team spirit by recognising people informally in person, meetings & emails and formally through the Abbott recognition system.Requirements Prior product development team lead or team member with experience in working with cross-functional teams such as Global Strategic Marketing, Market Access, Research & Development, Medical Clinical & Scientific Office, Quality, Regulatory, Operations, Procurement, Component Engineering, Supply Chain, Finance etc.Fluent business/technical English speaker with excellent interpersonal, listening, communication & presentation skills. Experience in working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience. Comfortable presenting to leadership in large global review settings.Skilled in translating strategic ideas into executable plans while flexing with ambiguity & fast paced change.Skilled in project management & problem solving across multiple projects (minimum 2 concurrently); with proven success with respect to timelines & budget management.Comfortable with geographically spread matrix organisation & operating across multiple time zones.Perform other duties and projects as assigned.Experienced in Design Control, QMS + Document Control for Medical Devices.Experienced in creating/shaping new processes.Can work with MS Office, Teams, Project, Excel, PowerPoint etc.Must Have: STEM Qualification10+ Years in Med Tech IndustryDesirable: PMP or equivalent certification in Project Management.
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