Labeling Project Manager

Abbott; Plymouth (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement plan with high-em

Tuition reimbursement and education

Job summary

Abbott in Plymouth, MN is seeking a Labeling Project Manager to lead and implement projects for the Labeling and Universal Addendum Labeling teams. You will conduct analysis, manage master data, and collaborate with cross-functional groups to meet regulatory and project timelines.

The role requires strong program management experience, excellent communication, and the ability to resolve labeling and UAL challenges while complying with FDA and global regulations.

Qualifications

• BA or BS in Business, Engineering, Supply Chain or Operations Management or equivalent experience.
• Project management certifications preferred.
• Minimum 5 years medical device industry experience preferred.
• 2+ years leading large-scale, multi-functional programs preferred.
• Experience with FDA & EU regulations, GS1 and ISO standards.
• Strong written and verbal communication at all levels.
• Experience with ERP/PLM systems preferred (SAP/Windchill).

Responsibilities

• Develop, communicate, and drive detailed schedules for program deliverables.
• Create and manage labeling and UAL change processes in DM systems.
• Collaborate cross-functionally to resolve labeling inconsistencies.
• Monitor program risks and drive for resolution.
• Ensure alignment on objectives and tasks across teams.
• Manage labeling master data and workflow via IT systems.
• Meet concurrent deadlines and manage multiple tasks.
• Analyze large data sets to identify resolutions.
• Comply with global labeling regulations and requirements.
• Support QMS, EMS, FDA & world-wide regulations and company policies.

Skills

Project management

Regulatory compliance

Data analysis

Cross-functional teamwork

Communication

Problem-solving

Attention to detail

Leadership

Education

Bachelor's degree

Tools

SAP

Windchill

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.

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 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

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.