Sr. Labeling Specialist

2 weeks ago

Irvine, United States Redbock - an NES Fircroft company Full time

Labeling Project Specialist (12+ Month Contract)


A leading Medical Device company is in immediate need of 2 Sr. Labeling Project Specialists for a 12-month project that can be based out of any of the following locations: Irvine, CA, Minnetonka, MN, Arden Hills, MN, or Marlborough, MA. These are hybrid roles, the consultants must work at least 3 days/week onsite. These roles will support a R&D team with a major integration project.


The Senior Labeling Project Specialist (LPS) plans, manages, trains, and directs the creation and revision of product literature and labeling through their own work and through others. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures, regulations, and standards. The LPS ensures labeling deliverables are completed per the schedule and maintains a high standard of quality.


The LPS will work to streamline processes, cross-train personnel, and continuously improve. The LPS will engage with stakeholders and work collaboratively across functions, regions, and business units. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.


Responsibilities:

  • Managing product labeling projects.
  • Developing labeling project strategies and schedules to outline work plans, timelines, roles, and resources. Anticipate potential barriers and develop alternatives and mitigation strategies.
  • Facilitating training on labeling procedures and labeling software and systems.
  • Leading product labeling project teams to complete activities per policies and practices to produce and release product labeling deliverables.
  • Effectively communicating project statuses, challenges, and successes on a regular basis to project and functional management in various meetings.
  • Ensuring on-time completion of deliverables.
  • Monitoring and working with project management and functional management to address issues that could negatively impact schedule or quality.
  • Coordinating all product labeling deliverables (will vary by project), including labels, IFUs, and carton and pouch artwork, etc.
  • Leading cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule.
  • Fostering and improving content consistency across labeling.
  • Facilitating team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer.
  • Coordinating desktop publishing and labeling artwork generation.
  • Coordinating implementation/release activities of labeling deliverables, including elabeling.
  • Managing content changes (and mitigating the impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
  • Leveraging expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.


Qualifications/Requirements:

  • Associate degree or bachelor’s degree
  • 7+ years’ work experience in regulated industry
  • Medical Device experience
  • 5+ years Labeling experience
  • Direct labeling or technical writing experience desired
  • High attention to detail
  • Ability to manage several projects concurrently
  • Ability to learn new skills and adapt to business needs
  • Medical Electrical Equipment / Capital Equipment experience
  • Adobe Suite Creative Suite experience strongly preferred
  • MS Office and MS Project experience strongly preferred
  • Project Management experience
  • Prisym, Bartender or other label design software and database experience preferred
  • Scrum and agile methodology experience preferred

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