Labeling Project Manager

Abbott (abbottcareers2 board); United States; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Plymouth, MN seeks a Labeling Project Manager to lead labeling and UAL initiatives, coordinating with cross-functional teams to meet regulatory requirements and project timelines. You will manage master data, drive change processes, and analyze data to resolve labeling challenges.

The role emphasizes program management, organizational excellence, and effective communication across diverse stakeholders within a global healthcare company.

Qualifications

• BA/BS in Business, Engineering, Supply Chain Management or related field.
• Project management certifications preferred.
• Minimum 5 years medical device industry experience preferred.
• 2+ years of leading large-scale, multi-functional programs preferred.
• Regulatory knowledge of FDA and EU requirements; GS1 and ISO standards.

Responsibilities

• Develop, communicate, and drive detailed schedules and timelines for program deliverables across multiple functions.
• Create and manage labeling and UAL change processes within document management systems.
• Collaborate cross-functionally to resolve labeling and UAL inconsistencies to meet requirements and timelines.
• Monitor program risks and issues and drive resolutions.
• Ensure cross-functional alignment on objectives and tasks.
• Manage labeling and UAL master data and workflow via internal IT systems.
• Handle concurrent deadlines and ensure timely delivery of tasks.
• Analyze large data sets to identify resolution methods.
• Comply with worldwide labeling regulations and quality systems.

Skills

Project management

Cross-functional leadership

Communication

Data analysis

Education

Bachelor's degree

Tools

SAP

Windchill

ERP systems

PLM systems

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position will work out of our Plymouth, MN location.

The Labeling Project Manager

The Labeling Project Manager will be responsible for meeting business needs by supporting the Labeling and Universal Addendum Labeling (UAL) teams by leading/implementing projects, conducting analysis, developing managing master data, communicating with cross functional teams, and problem-solving various challenges. Top candidates will have demonstrated skills in utilizing program management methodologies, excellent organizational and problem-solving abilities, and exceptional communication skills.

What You'll Work On

• Develop, communicate, and drive detailed schedules and timelines for program deliverables across multiple organizational functions.
• Create and manage labeling and UAL change processes within the document management systems.
• Work cross-functionally to identify and resolve labeling and UAL inconsistencies to meet applicable requirements and project timelines.
• Monitor for program risks and issues, and drive for resolution.
• Ensure cross functional alignment on objectives and tasks.
• Manage Labeling and UAL master data and workflow via internal IT systems.
• Manages concurrent deadlines and meets deadlines for assigned work/tasks.
• Analyze and interpret large data sets and identify methods of resolution.
• Complies to world-wide Labeling regulations and cross-functional business requirements.
• Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.

Required Qualifications

• BA or BS degree in Business, Engineering, Supply Chain Management and/or Logistics, or Operations Management or equivalent combination of education and work experience.
• Project management certifications preferred.
• Minimum 5 years medical device industry experience preferred.
• 2+ years of successfully leading large-scale, multi-functional programs preferred.
• Ability to manage projects and drive them to completion with attention to detail.
• Requires ability to be innovative, resourceful, and work with minimal direction.
• Knowledge of FDA & EU regulations, GS1 and ISO standards.
• Strong written and verbal communication, at all organizational levels.
• Ability to work within a team and as a leader in a fast-paced, changing environment.
• Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling, or UDI preferred.
• Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill.
• Database management and/or analytics software knowledge preferred.
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access.

Additional Information

The base pay for this position is $61,300.00 - $122,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

SH Structural Heart

LOCATION

United States > Minnesota > Plymouth : 5050 Nathan Lane N

Abbott is an Equal Opportunity Employer, committed to employee diversity.