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J&J Family of Companies Business Excellence Lead - Labeling in Madison, Wisconsin

Business Excellence Lead - Labeling - 2406200603W

Description

NeuWave Medical Inc , a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Business Excellence Lead - Labeling to join the NeuWave Operations team in Madison, WI!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today!

The Business Excellence Lead will be responsible for driving end to end execution of strategic initiatives that involve product development, regulatory, compliance, and supply chain strategies for both new and commercialized products. They will be accountable for strategic decision making in support of the overall product portfolio and take the lead in designing and coordinating project activities.

Key Responsibilities:

  • Initially responsible for labeling project portfolio management across new product development and lifecycle management to support on time launches and design change implementation.

  • Partner with Product Development, Supply Chain, Quality, Regulatory, and Marketing to develop strategies and process improvements to support overall business objectives.

  • Accountable for completing Design Control documentation and execution for label development.

  • Responsible for completion of Label Assessments, redlines of IFU/artwork, IFU Creation forms and ACCLM content sheets/DCAF.

  • Coordinate with external partners to translate labeling to support global distribution of product.

  • Work with planning for phase in/phase out of changes considering commercial, quality, or regulatory strategies and ensure timely implementation.

  • Maintain product label design and process knowledge for responsible platforms.

  • Lead projects as appropriate for unplanned event responses or planned changes. Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of quality supply.

  • Lead and/or support Non-conformances /CAPAs related to labeling as needed.

  • Know & follow local Quality System policies & procedures.

Qualifications

Qualifications

Education: Minimum of a Bachelor’s and/or equivalent University Degree required; focused degree in Engineering, Business or related field is preferred.

Experience and Skills:

  • Minimum of four (4) years of relevant professional work experience.

  • Understanding of compliance and regulatory requirements for medical devices and labeling.

  • Understanding of manufacturing, packaging, and labeling processes within a regulated field.

  • Experience influencing business partners to deliver ambitious projects.

  • Strong interpersonal and influence skills.

  • Excellent communication and presentation skills.

  • Ability to lead multiple assignments or projects with sound analytical and problem-solving skills.

  • Excellent planning and organization skills.

Preferred:

  • Medical device labeling experience.

  • Consistent track record of delivering projects on time and on budget.

  • A Project Management Professional certificate.

Other:

  • May require up to 10% domestic and/or international travel to other locations and sites.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-Wisconsin-Madison

Organization NeuWave Medical, Inc. (6229)

Travel Yes, 10 % of the Time

Job Function Project Engineering

Req ID: 2406200603W

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