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Menlo Park, California Abbott Laboratories

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 107,000 colleagues serve people in more than 160 countries

Structural Heart 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. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

Primary Function/Goals/Objectives:

  • Demonstrate stewardship and provide leadership through the Label Process to meet Division strategies and business objectives.
  • Support the Business Unit's short and long-term sales and profitability goals through the effectiveness of the Label Process to optimize the Business Unit's (BU) speed to market efforts.
  • Champion the Label Process across MitraClip business.
  • Identify and leverage opportunities to drive improved label process (e.g. culture, training, processes, tools, standards, etc.).
  • Provide long term vision and strategies to meet Division long term goals.
  • Manage, refine and ensure clarity and adherence to the label process, keeping current and visible BU-specific success criteria across BU's and cross-functional areas (Product Research & Development,, Regulatory, QA, Purchasing, Packaging Engineering and Marketing).
  • Develop effective communication systems that align efforts of labeling personnel and external supply partners to achieve strategic objectives.
  • Identify Labeling Process metrics and reporting.

Major Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system. Provide leadership and oversight of labeling in key project portfolio and Label Process data management between Label Process and key functional areas/processes such as Strategic Labeling sites, Regulatory, QA, Purchasing, Package Engineering, and International Marketing Affiliates.
  • Oversee and manage the Labeling Services processes, systems, and communications.
  • Guide the development of and implementation of training and tools to support the Label Process and build label process compliance/understanding across the Division.
  • Build organizational capabilities in project management.
  • Identify and lead process for obtaining feedback from key stakeholders for continuous improvements to Label Process.
  • Identify resource gaps between labeling project plans and business objectives.
  • Collaborate with Project Managers to acquire, maintain and share (as appropriate) lessons learned from the label process and individual project execution.
  • Enable better decision-making by leading and ensuring cross-functional areas understand and comply with division label process guidelines, standards and procedures.
  • Assist and guide Project Managers and Label Editors in resolving challenges/issues with upper management.
  • Financial Management: Responsible for expense budget management
  • Adheres to all corporate and divisional financial and compliance policies, and that all necessary documentation is maintained.

People Management:

  • Directly manages the Menlo Park Labeling team. Provides coaching, mentoring, and effective oversight of the team. Responsible for deploying personnel effectively to meet changing needs of the division and manage through priority demands to support divisional growth. Provide assessment/performance feedback to direct reports. Development of comprehensive training plan and career-path for staff including succession plan for direct reports.
  • Supplier Management:
  • Sets expectations and directs management of key suppliers and vendors related to label/IFU production. In conjunction with Purchasing, collaborate on supplier partner selection to ensure quality service levels and effective cost management.
  • Communications Management:
  • Must possess strong written and oral communication skills and present to management and to
  • extended teams. Must be able to develop effective presentations that outline strategy, goals and
  • implementation. Must demonstrate effective interpersonal skills in direct dealings with senior
  • management. Must be effective in dealing with conflict and construct win/win solutions.

EDUCATION & EXPERIENCE YOU'LL BRING:

Education:

  • Bachelor's degree required and/or 10 years experience in a managerial role.

Background:

  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals products.
  • Subject Matter Expert in Labeling. Individual must have a broad experience to establish and maintain credibility across functions and with Sr. Management. Knowledge of label production process. Knowledge of color management, print quality management and industry standard printing methods. Individual must possess competency in financial analysis and budget management.
  • Requires at least 7-10 years of experience (project management, marketing, business, management of direct reports).This position is responsible for the control of documentation and labeling records contained within Labeling Services for exported manufactured MitraClip products. This individual ensures that adequate training programs are developed and maintained. He or she must be able to rearrange priorities on short notice to react to customer needs and provide project leadership for various teams addressing quality improvements. This includes managing major dept. / divisional computer systems related to documentation and labeling and providing expertise on new system development and control of these systems in conjunction with ANI Label Control centers. The position is responsible for drafting and approving division labeling policies. Providing support to affiliates with labeling initiatives.
  • Basic knowledge of regulations and standards affecting pharmaceutical, hospital (drug/device), and nutritional products.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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