Sr. Specialist, Labeling Design

14746BR

Job Description:

Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation. Job duties:

• Develop strategies for continuous improvement of the Labeling program and procedures.

• Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system.

• Provide advice or consultancy to other teams with respect to labeling implementation processes.

• Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software.

• Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables. Develop standardized and optimized label templates and identify issues associated with design.

• Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.

• Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.

• Coordinate with suppliers and vendors for outsourced printed products and translated materials.

• Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances. Lead activities to implement corrective actions.

• Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives.

• Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities.

• Communicate anticipated assignment completion dates to affected coworkers. Meet timeline commitments with minimal supervision.

• Perform other responsibilities as assigned.

Qualifications:

1. Bachelor’s degree in related field or equivalent combination of education and experience.

2. A minimum of five (5) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and in labeling and digital design software platforms, including labeling database management.

3. High level of attention to detail and sustained focus.

4. Project management skills and experience.

5. Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.

6. Excellent problem-solving, organizational, analytical, and critical thinking skills.

7. Ability to work in a cross-functional environment while building positive internal/external working relationships.

8. Excellent written and verbal communication skills.

Desired Qualifications

1. Extensive knowledge and efficient use of Enterprise Label Management software (e.g., Teklynx Codesoft, Loftware Spectrum, PRISYM 360, etc.). Extensive knowledge of Adobe Creative Suite (e.g., Illustrator, InDesign, Photoshop, etc.).

2. Moderate knowledge of Product Lifecycle Management software (e.g., Windchill, Agile, Teamcenter).

3. Ability to create CAD drawings and perform intermediate level tasks in SOLIDWORKS.

4. Knowledge of FDA and global regulations as it relates to labeling requirements and documentation.

5. Understanding of domestic and global labeling implementation.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Posting Country:

US - United States

Title:

Sr. Specialist, Labeling Design

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.