Labeling Specialist

Who We Are:

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

What you'll do:

The Labeling Specialist will be responsible for supporting all labeling functions. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

• Responsible for coordination of all product labeling deliverables, including labels, IFUs/DFUs, and carton and pouch artwork, work instructions, DHR records, etc.
• Coordinate and manage creation/revision of deliverables from project initiation through completion.
• 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, when necessary, 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 client’s Document Control System.
• Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
• Approve and release labeling content (IFUs, ORMs, patient ID cards, etc.), product labels, packaging components (cartons, pouches, lids, etc.), FAI reports for all new packaging components and product labeling.
• Develop or support delivery strategy for all product labeling (i.e. literature packets, e-labeling)
• Support regulatory submissions (by product/by country)
• Regularly report to various levels of ECI/client management on the progress of project.
• Work and interact effectively and professionally with and for others throughout various levels of the ECI and client organization
• Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors

What We're Looking For:

• Associate or Bachelors degree
• Minimum 4 years of experience in a regulated industry; some of which must be in medical devices
• Minimum 2 years Labeling experience
• Adobe Creative Suite, MS Office and MS Project experience strongly preferred
• Bartender, NiceLabel or similar label design software and database experience preferred

ECI does not accept unsolicited resumes from third-party recruiting agencies not currently under a signed agreement. Any unsolicited resumes that are sent to directly to ECI or its employees by a third-party recruiting agency not currently under a signed agreement with ECI, will be considered property of ECI. If a third-party recruiting agency submits a resume without an agreement, ECI reserves the right to pursue and hire those candidate(s) without any financial obligation to the third-party recruiting agency.

Enhanced Compliance Inc. is an equal opportunity employer.