Staff Labeling Specialist

Position Summary

Assists in the timely development and completion of labels, package inserts, clinical reports, summary documents, and other documents. May oversee the electronic regulatory submission process. Oversees and provides recommendations for the development of formats and guidelines for documentation.  Ensures effective planning and management of timelines for all aspects of technical documents.  Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products. Monitors process of any changes in labeling regulations in the US and/or abroad. Reviews labeling change information and ensures that it is supported by the data and consistent with the application.

General Requirements

• Excellent interpersonal communication and collaborative teamwork skills
• Ability to communicate effectively with team members, management, and subject-matter experts.
• Utilize proper software to maintain project records such as Label Systems, PPM system, MS Office or SharePoint.
• Technical aptitude for systems and tools and analytical thinking
• Well organized, able to support multiple projects. Project management skills. Able to meet deadlines.
• Proven ability to implement medium-large scale projects. Generate and explain detailed schedules and performance objective.
• Demonstrated experience in presenting to mid-level management
• Customer service oriented. Able to work with internal teams and external services.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Key Areas of Responsibility

• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle
• Exercises judgement in determining approaches to assignments and objectives. Exercises discretion and independent judgment with respect to matters of significance – such as budgets. May lead and train lower level employees.
• Monitors process of any changes in labeling regulations in the US and/or abroad.
• Ensures the global initiatives in their area are communicated and understood by divisional stakeholders
• Aware of cultural differences that may exist in regulatory requirements and technical practices. See impact of new and changing requirements. Spread awareness of country-specific needs. Provides accurate estimates on cost and time impact. (Monitor and communicate global regulatory needs to larger NPD teams. Cross cultural communication) Opportunity to work with various global teams.
• Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership
• Support gap analysis for labeling standard updates for impact to labels
• Coordinates input, feedback, and represents their division's needs
• Serves as the voice for their division in the process area and represents their division at hub and spoke meetings
• Complete understanding and application of tools and understanding of medical device labeling compliance.
• Experienced in modifying existing Quality System documentation
• Must be highly engaged with team and success of team goals
• Familiarity with product labeling strategies.
• Supports continuous improvement activities for functional area
• Able to assess impact on label changes; UDI impact; additional translations, supplemental labeling (includes distribution strategy), etc
• May review and provide input for Technical Documents and GSPRs.
• Support NC/CAPAs efforts (effectivity checks). May be NC owner.
• SME for audit front room support
• Investigates solutions to complex technical problems.
• Networks with others cross-divisionally in area of expertise and influence.
• General understanding of other related disciplines – example risk management, product safety, clinical sciences, etc.
• Benchmarking of labeling tools, strategies, translation services and topics pertaining to medical device labeling.
• Manage translation process/procurement, quality of translated documents

Qualifications Knowledge  Skills

• B.S. or Equivalent experience
• >4 years of experience
• Prior divisional or site experience desired