Principal Labeling Specialist

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 114,000 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 works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. 

As a Principal Labeling Specialist, you will have responsibility within the Artwork and Labeling Development group to ensure the timely and accurate delivery Abbott Diabetes Care and Lingo 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 role in Alameda, CA.

What You'll Work On

• 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. 

Required Qualifications:

• 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.
• Goo