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Principal Labeling Specialist

4 months ago


Alameda, United States Abbott Laboratories Full time

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre 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. Youâll 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 bachelorâs 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 weâre 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 YOUâLL 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.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ï¬ngersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Diabetes

Weâre focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission:  why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

EP

In Abbottâs Electrophysiology (EP) business, weâre advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbottâs Heart Failure (HF) business, weâre developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

Weâre empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbottâs diagnostics instruments, providing lab results for millions of people.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the worldâs greatest healthcare challenges.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands â including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® â to help them get the nutrients they need to live their healthiest lives.



The base pay for this position is $95,500.00 â $190,900.00. In specific locations, the pay range may vary from the range posted.