Labeling Project Manager
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What you'll do
- 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.
What they're looking for
- BA or BS degree in Business, Engineering, Supply Chain Management and/or Logistics, or Operations Management or equivalent combination of education and work experience.
- 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.
- 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.
Nice to have
- Project management certifications preferred.
- Minimum 5 years medical device industry experience preferred.
- 2+ years of successfully leading large-scale, multi-functional programs preferred.
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 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.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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 – $122,700.00In 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
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Company
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