Program Manager, Labeling

Job Summary

The Labeling Program Manager is responsible for supporting labeling related project design input and verification / validation / program management activities across the Labeling Team and across the end-to-end labeling process(es) within the Fresenius- Kabi MedTech Transfusion and Cell Technologies (TCT) Division.
This role applies specialized knowledge to realize labeling requirements and process strategies across existing and new product development. This role will drive project execution in accordance with design & change control requirements and global medical device regulations for medical devices, drugs, and combination products manufactured by Fresenius Kabi MedTech TCT Division facilities and affiliates.

Labeling Team scope includes development of strategy, creation, and management of global labeling requirements, specifications and released artwork for multiple types of manuals, instructions for use, package inserts, release notes, product, and package labeling in addition to providing leadership and operational support for Global UDI and Global eIFU activities. Scope of team also includes the implementation and maintenance of labeling related platforms and tools and harmonizing legacy processes and practices across TCT and MedTech locations.
Responsibilities

This role facilitates and coordinates the efforts of team members, cross-functional stakeholders, and labeling related service suppliers to deliver project deliverables per commitments. Specific activities may include, but are not limited to:
1) Serve as technical expert in global labeling requirements definition – including global regulatory, technical and standards-based requirements, risk mitigation requirements, and commercial requirements.
2) Develop and author formal Labeling Requirements Specifications (Design Inputs) and align global labeling requirements with other product design inputs. Mentoring / training others across product portfolio, as needed. Review and approve labeling related DHF documentation, as needed.
3) Build and Maintain master global labeling requirements tool in DOORS/ PLM.
4) Drive global labeling related design control strategy – including requirements, verification/ validation, traceability.
5) Strategic planning, program management and support of data collection of regulated product data across portfolio for Global UDID syndication
6) Program management across multiple process improvement initiatives / labeling related workgroups Act as liaison between technical and non-technical departments, facilitating cross-team collaboration and understanding of comprehensive labeling design control requirements. Organize and track projects, proactively manage risks, manage project escalations, prioritize tasks, and meet specific business objectives.
7) Support the implementation planning of eIFU across product portfolio
8) Labeling Team related performance analytics and metric reporting
9) Labeling related operational execution support – including back up for Labeling Team Project Tracker, Labeling Systems implementation, and maintenance activities,
10) Own and maintenance of labeling team related SOPs, WI, Tools, as needed
11) As part of Labeling Leadership Team, this role has shared responsibility and accountability for ensuring the Quality, global compliance and business process requirements are met across end-to-end labeling activities (including Global UDI) and that labeling related policies and related objectives are established and are compatible with the strategic direction of the organization.
12) All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
13) Other labeling team related activities as requested.

Requirements

• Bachelor’s Degree required
• Minimum of 5 years previous related labeling experience.
• Ability to author (in English) concise verifiable global labeling requirements
• Ability to distill complex process content, requirements, challenges etc. to brief, concise, and understandable language when communicating across teams
• Manage concurrent projects and priorities, develop project schedules and effectively communicate project status and activities to stakeholders
• Recognize and define big picture and be detailed oriented on project / program / product details – with adaptability to recognize and communicate shifts in strategy, priorities, or implementation needs
• perate independently and effectively under committed timelines
• Knowledge of FDA, MDR, ISO Standards, GS1 Standards and other global industry regulations and standards related to labeling, barcoding, symbols, eIFU, etc.
• Knowledge of medical device regulated environments, including GDP, GLP, GMP, and regulated Quality Systems
• Strong interpersonal skills, including effective verbal and written communication and negotiating skills
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio….)

. Experience with DOORS, PLM systems, and regulated master data management preferred

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Type: Full-time

Pay: $118,000.00 - $127,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance

Experience level:

• 5 years

Work Location: Hybrid remote in Lake Zurich, IL 60047