Overseeing IFU project management and process standardization for Johnson & Johnson's cardiac team. Developing operational strategies for smooth project execution and regulatory compliance.
Responsibilities
Accountable for ensuring IFU changes align to project timelines and Quality systems
Leads overall orchestration and prioritization of IFU projects
Maintains oversight of IFU production backlog including driving execution of production tasks, and ensuring status of projects and activities is accurate and current
Facilitate cross-functional and cross-platform projects, communications, and governance
Drives consistency and efficiency of processes and facilitates continuous improvement
Ensures all requests follow standard processes and contain required information
Facilitates communication between project originators, Product Managers, labeling experts and any other parties to clarify requirements
Maintains tracking of new, in-flight and released projects in Roadmunk tool
Provides reporting on project status including risks and actions required, escalating appropriately as needed
Works with Project Teams to align on priorities, including balancing potentially competing business objectives
Creates and coordinates production tasks, driving accountability for timely and accurate execution
Engages with translation vendor, ensuring timely and accurate delivery of certified translations
Maintains project backlog and contributes to defining execution strategy
Hosts regular strategy and project review meetings and facilitates executive communication
Supports internal operations goals including system and process improvement, strategic initiatives, stakeholder enablement, SharePoint site maintenance, etc.
Drives continuous improvement in systems, process, and communications
Requirements
Minimum 6 years of work experience with 5 years of experience in Operations, Product Lifecycle, or Project Management, preferably in MedTech or other regulated industry
Bachelor’s degree preferred
Proficiency in Microsoft Office365, Adobe Acrobat
Experience with Project Management tools (e.g., Smartsheet, Roadmunk, or similar)
Strong communication and collaboration skills, including experience coordinating diverse cross-functional teams
Strong skills in project governance, status reporting, and risk/issue management
Tolerance and flexibility within a fast-paced environment
Attention to detail including review of written materials
Strong understanding of labeling, technical documentation, regulatory compliance, and other product lifecycle requirements preferred; relevant experience could include Quality Systems, Document Control Operations, Sr. Tech Writers, Process Owners/Engineers
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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