At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we’ve stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.
This newly created role will be responsible to build and manage the Point of Care Product Labeling team, which will be responsible for content development for product documentation, end-user instructions, operator’s manuals and other labeling or documentation for Abbott Point of Care products.
The position reports into the Director of Regulatory Affairs.
Core responsibilities include:
1. The Manager will be responsible for building and managing a team that is responsible for the creation and maintenance of product labeling content.
2. Manager Product Labeling ensures that all labeling requirements are met for new products and for existing product changes.
3. The Manager will work closely with Regulatory Affairs and Product Development teams to ensure compliance to global product labeling requirements throughout the product life cycle.
4. The Manager acts as the Process Owner by continuously improving product labeling processes and updating the relevant SOPs. He/she facilitates communication among key stakeholders for country specific requirements in product labeling, and manages labeling content and language translations to support business growth.
5. The applicant should be a strong leader and manager, and will develop resourcing strategies, allocate staff, tools and specialized support necessary for efficient operations.
6. The successful candidate may develop innovative strategies to improve time to markets, proactively monitor global new or revised regulations, and implement actions to ensure completion of product labeling deliverables, while assuring that there are no significant interruptions to the business due to quality or compliance issues
This position requires someone with in-depth knowledge of technical writing or instructional design principles, tools, practices and procedures. Content deliverables may include product documentation, end-user instructions (IFUs and Product Inserts), Operator’s Manuals, online help and release notes. The manager may represent the Product Labeling function on project teams or cross-business projects.