Principal Labeling Specialist

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Project Specialist Label Packaging, you will have responsibility within the Artwork and Labeling Development group to ensure the timely and accurate delivery of the division's product labeling. This position will work with both internal and external stakeholders to support the labeling needs for new product launches or updates to existing products. They are also responsible for leading their staff's performance and development. This is an onsite opportunity in Alameda, CA.

What You'll Do

• Balance, align, and prioritize day-to-day activities of staff to support Artwork and Labeling Development projects.
• Effectively work with cross-functional team (e.g. R&D, Regulatory, Operations, Quality, Marketing) to develop labeling and packaging that meets the requirements of the FDA and international regulatory agencies, internal brand/design requirements, and manufacturing specifications.
• Independently manage large-scale labeling change projects.
• Communicate labeling projects and priorities across the division, plan project timelines which may involve managing multiple, concurrent deadlines.
• Complete assessments for projects to identify scope and impact to labeling.
• Work with cross-functional team to understand impact of changing regulations and product requirements regarding labeling.
• Manage the translation of packaging and labeling items with translation supplier.
• Troubleshoot issues, communicate impact, and propose solutions.
• Create and manage change control packages in product life cycle management system, and ensure that documentation is accurate, appropriate, and justified.
• Manage and supervise staff by creating an environment that fosters collaboration, accountability, trust, innovation, and respect.
• Assist with hiring qualified staff and provide ongoing performance feedback. Set goals which align to department plans and manage the execution of goals through coaching and mentoring. Cultivate development and growth through training, guidance, and support.

EXPERIENCE YOU’LL BRING

Required:

• Bachelors Degree and/or equivalent combination of education and work experience
• Minimum 4 years of experience in a regulated industry and/or experience in related operations areas such as manufacturing, materials management, quality control, quality engineering, document control, compliance, auditing, engineering and/or regulatory.
• Experience working with policies and procedures impacting documentation and documentation practices. Strong oral and written communication skills.
• Must know correct English grammar and syntax.
• Good people relations, able to work independently with good administrative and time management skills. PC and Microsoft Office experience.
• Must be able to perform detailed, careful work, including proofreading of numerical values, equations, etc.

Preferred:

• Substantial experience coordinating and executing project activities in a highly regulated industry.
• Experience with medical device labeling or labeling for highly regulated industry.
• Experience with print production.