Labeling Analyst

Labeling Analyst

Our client is looking for a Labeling Analyst.

The Lifecycle Labeling Analyst is responsible for:

• Under very limited to no supervision and at times independently coordinates lifecycle product labeling content input collection. Collaborating cross-functionally with designated subject matter experts (SME).
• Is responsible for assuring all required design inputs are captured and properly documented per franchise procedures.
• Provide required documentation to project management and design execution teams.
• Responsible for the content collection accuracy, completeness and consistency, across product families and franchises.
• Load inputs and information into quality system as required.
• Project Lead for the label changes as a subset of the broader change project. (i.e Label change required as a result of another project driver such as device, manufacturing location change).
• Expected to run projects using project management tools and methods this includes kick off meetings, project plan development and management, risks and issue logs, mitigations, status updates and metrics.
• Represents the Labeling COE to customer groups and escalates as appropriate within the labeling COE to meet the needs and respond to requests and inquiries from the business.
• Proactive participation within teams to include inputs of labeling project line items to broader project plan, identification of risks, mitigations and solutions to insure success of achieving overall project goals.
• Proactive communication to insure understanding of label project plan, risks, issues, mitigations, status updates, and metrics.
• Collaboration with peers across the COE to support continuous improvement in processes and execution.
• Collaboration cross functionally in a way that builds relationships, educates others on process and is seen as someone who stands for excellence in execution and is a valued member of the team that enables success of others and team goals.

Key skill/knowledge requirements:

• Work effectively - with general direction / minimal supervision - following standardized practices & procedures
• Communication written, verbal and across digital mediums necessary for communicating across required stakeholders
• Knowledge of Documentation systems
• Negotiation, influencing and consensus building
• Able and willing to guide others in area of specialty
• Multi-tasking manage multiple projects with aggressive project deadlines
• Project management methodology
• Able to advocate and coach, representing the brand of the labeling COE and business processes.
• Personal computer skills, Windows: word processing, project planning, Microsoft projects, excel, presentation, e-mail/Internet.
• Proficient in Business applications and supplier portal technology required for role.
• All other software as identified for this position.

Job experience:

• 3-5 years' experience with at least 1-3 years' experience related directly to the development of package labeling preferred.
• Demonstrated project coordination with successful results.
• Demonstrated achievement of metrics, process improvements preferred.

Key job responsibilities:

• Know and follow company policies and procedures related to work activities performed in area of responsibility.
• Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for the implementation of new policies and procedures. Complete required periodic re-training in areas such as safety and environmental. May have accountability for training new contract hires.
• Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area.
• Support multiple projects simultaneously, must be well organized and flexible to handle multiple tasks.
• Must be able to communicate and interact with all levels of Management as well as cross-functional teams.
• Contribute to continuous departmental process improvement efforts.
• Knowledge of worldwide labeling regulations and corporate directives impacting product labeling are of critical importance.
• Ability to function in an environment undergoing constant worldwide regulatory change.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Interface with assigned project teams to identify labeling requirements.
• Verifies that all executed materials as per established company procedures & authorize their accuracy
• Maintain all documentation according to GMP (Good Manufacturing Practices)
• Initiate process improvements as appropriate
• Other responsibilities may be assigned & not all responsibilities listed may be assigned

Post hire training plan requirements:

• Training Plan Requirements as identified in Corporate Training Procedures

Physical demands:

• Office deskwork, requiring sitting, walking, using the phone and computer
• Extended periods of time at computer terminals and viewing computer screens

Work environment: Office environment

Supervisory responsibilities: This role has no supervisory responsibilities

Travel requirements: Little to no travel may be required

Qualifications

Education / Degree required:

• B.S./B.A. degree or qualifying combination of education & work

Experience in technical writing for regulated industries preferred

Project Management Certification preferred

Additional Information

Regards

Savita Khashu

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE | GSA - Schedule 66 I GSA - Schedule 621 I

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