Labeling Project Specialist — Medical Device (Hybrid –Minnetonka/Arden Hills, MN) Contract – Level I - Pharmavise Corporation
Minnetonka, MN 55345
About the Job
Our Fortune 500 Medical Device client has an exciting opportunity for a Labeling Project Specialist.
Job Summary:
The Labeling Project Specialist (LPS) plans, manages, and directs the creation/revision of product literature and labeling. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures. They develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.
Responsibilities:
Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, 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.
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, including e-labeling.
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.
Identify and implement opportunities for continuous improvement and innovation.
Job Requirements:
Associate degree or bachelor’s degree
4+ years’ work experience in regulated industry
Medical Device experience
2+ years Labeling experience
Direct labeling or technical writing experience desired
Medical Electrical Equipment / Capital Equipment experience
Adobe Suite Creative Suite experience strongly preferred
MS Office and MS Project experience strongly preferred
Project Management experience
NiceLabel, Bartender or similar label design software and database experience preferred
Scrum and agile methodology experience preferred
Ability to travel up to 15% including some international travel.
Skills Required:
Product labeling experience (preferably in med device or other regulated industry)
Project management skills
Collaborator with cross-functional team members to develop labeling content
Other Details:
Schedule: Full-time
Contract Length: 12 months
Work Set-up: Hybrid in Marlborough, MA; Minnetonka, MN; Arden Hills, MN; Irvine, CA
Travel up to 15% including some international travel.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
Job Summary:
The Labeling Project Specialist (LPS) plans, manages, and directs the creation/revision of product literature and labeling. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures. They develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.
Responsibilities:
Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, 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.
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, including e-labeling.
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.
Identify and implement opportunities for continuous improvement and innovation.
Job Requirements:
Associate degree or bachelor’s degree
4+ years’ work experience in regulated industry
Medical Device experience
2+ years Labeling experience
Direct labeling or technical writing experience desired
Medical Electrical Equipment / Capital Equipment experience
Adobe Suite Creative Suite experience strongly preferred
MS Office and MS Project experience strongly preferred
Project Management experience
NiceLabel, Bartender or similar label design software and database experience preferred
Scrum and agile methodology experience preferred
Ability to travel up to 15% including some international travel.
Skills Required:
Product labeling experience (preferably in med device or other regulated industry)
Project management skills
Collaborator with cross-functional team members to develop labeling content
Other Details:
Schedule: Full-time
Contract Length: 12 months
Work Set-up: Hybrid in Marlborough, MA; Minnetonka, MN; Arden Hills, MN; Irvine, CA
Travel up to 15% including some international travel.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
Labelling, Medical Device
Source : Pharmavise Corporation