Senior Project Manager

🕒 vor 19 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

👷‍♀️ Projektmanager

👻 Geisterscore 10%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Meridian Bioscience Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🍽️ Lebensmittel & Getränke

💰 Grant im 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. ist ein führender Hersteller von molekularen und immunologischen Reagenzien, die für diagnostische Anwendungen entwickelt wurden. Das Unternehmen ist darauf spezialisiert, innovative Lösungen zur Verbesserung von Point-of-Care-Diagnostik und zur Optimierung der Testentwicklung für verschiedene medizinische Bedingungen, einschließlich Infektionskrankheiten und Krebs, bereitzustellen. Meridian engagiert sich für den Fortschritt der medizinischen Diagnostik und die Verbesserung der Patientenresultate durch seine hochwertigen Produkte und Dienstleistungen.

Beschreibung

• Lead complex, cross-functional new product development projects for in vitro diagnostic assays and diagnostic instrument systems • Manage project planning and execution from concept through launch • Define project scope, goals, deliverables, success criteria, and governance • Develop and maintain integrated project plans, timelines, critical paths, dependencies, resource needs, and key decision points • Communicate project plans and changes to team members and leadership • Drive team ownership and commitment to project plans • Identify risks, issues, tradeoffs, and required changes to meet project objectives • Track, analyze, and communicate project performance, including schedule, milestones, risks, resources, and budget • Provide status updates, forecasts, and escalations to leadership • Ensure on-time completion of deliverables in accordance with commitments, design control requirements, and company procedures • Lead and facilitate cross-functional project teams, decision-making, issue resolution, and alignment across functions and external partners • Partner with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, Marketing, and external development partners • Perform other duties as assigned

🎯 Anforderungen

• Bachelor’s degree in science, engineering or business administration or related field required • At least 7 years of project management experience leading cross-functional product development projects • Significant experience managing complex, multi-functional projects from concept through launch • Direct experience managing FDA-regulated in vitro diagnostic (IVD) product development projects • Proven track record leading IVD products through FDA clearance or approval and commercial launch in the U.S. market • Strong working knowledge of medical device design control requirements and product development processes • Experience with design planning, design reviews, risk management, verification and validation, transfer, regulatory submission, and launch readiness • Experience with IVD products, including assay and/or diagnostic instrument development • Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations • Project management qualification (PMP) or equivalent preferred • Advanced project management skills and practical project management experience, preferably in the diagnostic field • Successful leadership of product development projects with significant technical, regulatory, operational, and/or cross-functional complexity • Capability to perform critical path analysis, dependency management, risk management, and scenario planning • Excellent problem-solving and decision-support skills • Ability to prioritize competing demands, balance workloads and timelines, and work on multiple projects simultaneously • Ability to work independently with limited oversight while influencing and collaborating with peers, functional leaders, senior stakeholders, and external partners • Ability to meet strict deadlines and perform under pressure in a fast-paced work environment • Excellent interpersonal, organizational, written, and oral communication skills • Basic understanding of IVD product development, including assay and/or instrument development, engineering, verification and validation, regulatory, quality, clinical, manufacturing, transfer, and launch activities • Willingness to travel 20%

🏖️ Vorteile

• Travel as required to support project teams and key milestones • Remote work option • Travel allowance implied by required 20% travel