Location: Maple Grove, MN
Duration: 6-12 months (w/possibility of extension or full time hire)
- Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, patient labeling, etc.
- Manage and coordinate creation/revision of deliverables from project initiation through completion.
- Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources.
- Develop deliverable schedules and establish milestones for tracking progress. Ensure on-time completion of deliverables, and communicate project status, challenges, and successes on a regular basis to project and functional management.
- Understand and coordinate/monitor completion of key dependencies from other functions.
- Monitor and work with functional and project management to address issues that could negatively impact schedule or quality.
- Lead 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.
- Foster and improve content consistency across labeling.
- Facilitate 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.
- Coordinate desktop publishing and labeling artwork generation.
- Coordinate implementation/release activities of labeling deliverables.
- Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
- Implement product labeling via Boston Scientific’s Document Control System.
- Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
- Associate’s Degree
- 4+ years’ work experience in regulated industry.
- Medical device or pharmaceutical experience
- 2+ years Labeling experience
Education/Experience/Skills NOT required, but helpful:
- Direct labeling or technical writing experience desired.
- Bachelor’s degree
- Medical Electrical Equipment/ Capital Equipment experience
- Adobe Suite Creative Suite experience strongly preferred.
- MS Office and MS Project experience strongly preferred.
- Project Management