Labeling Coordinator Jobs
By Exactech At , Gainesville, 32653
Prior knowledge/experience to work with labeling systems (e.g. PRISYM)
An Associates degree preferred; or two years of equivalent on the job training/experience is required or
Bachelor's Degree with 1 year of related experience
Understanding of medical device labeling requirements, regulations and industry standards
Previous experience working in a medical FDA regulated industry
Excellent computer skills including usage of MS Office Suite
Regulatory Labeling Manager (Us-Remote)
By Amgen At , Los Angeles $95,277 - $134,309 a year
Project Management experience, experience managing individual and group projects of moderate complexity
Experience working in a Documentum-based document management system
Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone
Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
Manages the review and approval of core DHCP letters
Labeling Manager Jobs
By Edwards Lifesciences At , Irvine, 92614 $106,000 - $151,000 a year
Proven successful project management leadership skills
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Develop team members to increase business acumen and functional skills.
Bachelor's Degree and related Labeling experience
Master's Degree and 6-8 years of related Labeling experience
Experience working in medical device, pharmaceutical or FDA regulated industry
Global Labeling Manager (Oncology)
By Novartis At , East Hanover, 07936 $124,000 - $186,000 a year
Strong interpersonal, project management, communication, negotiation and problem solving skills.
Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.
Serve as the labeling lead for all labeling related topics.
Present to GLC on CDS changes.
Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries
Sr. Manager, Global Labeling (Remote)
By Takeda Pharmaceutical At , Boston $130,000 - $155,000 a year
Join Takeda as a Sr Manager., Global Labeling (Remote)
Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
What Takeda can offer you:
Leads cross-functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team).
Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team.
Senior Manager, Packaging & Labeling
By Alchemee (formerly The Proactiv Company) At Hawthorne, NY, United States
Education, Knowledge, Skills, & Abilities
Self-directed with excellent time management skills.
Responsible for measuring costs associated with each initiative as well as the management of the Product & Package Development budget.
Bachelor’s degree in Design, Visual Arts, Packaging or similar discipline is required. OTC packaging experience a benefit.
Manage routing process including feedback from clients and resolving issues, preflight projects, including review of proofs, color correction and production changes.
Manage complex projects and deliver innovative packaging solutions within the appropriate timelines.
Labeling Coordinator Jobs
By Exactech At United States
Prior knowledge/experience to work with labeling systems (e.g. PRISYM)
An Associates degree preferred; or two years of equivalent on the job training/experience is required or
Bachelor's Degree with 1 year of related experience
Understanding of medical device labeling requirements, regulations and industry standards
Previous experience working in a medical FDA regulated industry
Excellent computer skills including usage of MS Office Suite
Senior Program Manager, Data Labeling
By Pinterest At San Francisco, CA, United States
8+ years of program / project management experience
Manage a team of highly skilled program and project managers
Strong track of organizational management, budgeting, and resource management
Manage our multi million dollar budget from planning to monthly reporting in alignment with our quarterly forecast
Manage our vendors and negotiate contracts
A seasoned people manager with a passion for growing others
Senior Manager, Labeling & Graphics Operations
By Gilead Sciences At , Foster City, 94404, Ca $149,600 - $193,600 a year
Strong computer, organizational, and project management skills.
Contributes to the completion of all technical and operational activities for Labeling Operations projects through management of internal and external resources.
Manages complex processes across functions and interacts effectively with team members to ensure product labeling meets regulatory requirements.
Owns quality records such as CAPAs, Deviations, and Change Management related to labeling.
Strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents.
Evaluates the flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.
Data Labeling Specialist / Manager | Remote (100%)
By Tech Observer At San Francisco, CA, United States
·Manage and scope out multiple labeling projects in a highly cross-functional environment.
·Experience working independently and a track record of taking initiative
·Experience working with large data sets and keeping the quality high.
·Experience in Excel and/or SQL
·Impeccable communication and relationship-building skills
·Drive labeling workflows and projects success metrics and timeline.
Quality Manager, Labeling Jobs
By Vyaire At , Irvine, Ca
Must be capable of interfacing with executive level of management and health care professionals
Providing guidance, as required, on requirements
Demonstrating a broad knowledge of product development process
Knowledge of global medical device labeling regulations and standards (i.e. FDA, ISO 1485, EU MDR, etc.)
Additional qualifications that could help you succeed even further in this role include:
Providing leadership and direction to the Labeling team
Manager/Senior Manager Regulatory Labeling
By Karyopharm Therapeutics Inc. At , Remote $87,000 - $214,000 a year
Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.
Manages compounds with a high degree of complexity from a labeling perspective.
Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.
5+ years of experience in global and/or local regulatory labeling within the pharmaceutical industry.
Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
Labeling Associate Jobs
By AWH MGMT GRP LLC At , Franklin, 07416, Nj
Demonstrate accurately and thoroughly in a timely manner to meet production standards
Properly label and sticker product, in order to ensure fulfillment of deliveries
Work in collaboration with all members of the vault to ensure production standards are delivered upon
Ensure that the correct labels are affixed to the correct products
The ability to lift 25/50 pounds regularly
Able to work weekend and off hours
Data Labeling Analyst Jobs
By Facebook At Burlingame, CA, United States
Implement pre-approved changes to workflows and knowledge repositories.
Help support and exchange knowledge with other PDO DLAs.
Strategic & Organized: Ability to manage multiple projects/workflows/ communication channels simultaneously.
Organize logistics for data collection projects as needed.
Labeling Specialist - Remote
By Proclinical Staffing At Cambridge, MA, United States
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.
Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.
Manager, Manufacturing – Visual Inspection & Packing Labeling - Clinical Supply Operations
By Moderna Therapeutics At , Norwood, 02062, Ma
Vacation, sick time and holidays
Volunteer time to participate within your community
Paid sabbatical after 5 years; every 3 years thereafter
Here’s What You’ll Bring to the Table:
Generous paid time off, including:
Senior Regulatory Labeling Manager
By ICON At , Remote
Excellent project management, and critical thinking skills
Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions
10+ years of relevant experience
Advanced knowledge of the scientific principles of the drug development process
Advanced, broad knowledge of regulations pertaining to drug product labeling
Excellent oral and written and written communication skills
Senior Rep, Labeling Jobs
By Edwards Lifesciences At , Irvine, Ca $47,000 - $65,000 a year
Good time management and organizational skills
Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling operations
Good knowledge of labeling requirements across business units
Associate's Degree with 4 years of related experience OR H.S. Diploma with 6 years of related experience required
Good computer skills including usage of MS Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Senior Manager Of Labeling Operations
By Kite Pharma At , Santa Monica, Ca $136,000 - $176,000 a year
Excellent computer, organizational, and project management skills.
MA / MS Degree with 6+ years of Supply Chain and/or Project Management and/or Labeling experience
BA / BS Degree with 8+ years of Supply Chain and/or Project Management and/or Labeling experience
Associate Degree with 10+ years of Supply Chain and/or Project Management and/or Labeling experience
High School Diploma / GED with 12+ years of Supply Chain and/or Project Management and/or Labeling experience
Manages complex processes across functions and interacts effectively with the other team members to ensure product labeling meets regulatory requirements.
Associate Specialist, Labeling Jobs
By Edwards Lifesciences At Irvine, CA, United States
Bachelor's Degree with 1 year of related experience Required
Previous experience working in a medical/pharmaceutical FDA regulated industry
Excellent written and verbal communication skills and interpersonal relationship skills
Basic knowledge of medical device documentation development activities
Knowledge of ECR and Ignite processes
Good computer skills including usage of MS Office Suite

Are you an experienced Project Manager looking for a new challenge? We are looking for a motivated and organized individual to join our team and lead our Labeling Project. You will be responsible for managing the project from start to finish, ensuring that all deadlines are met and that the project is completed on time and within budget. If you have a passion for project management and a drive to succeed, this could be the perfect opportunity for you!

Overview A Labeling Project Manager is responsible for managing the development and implementation of labeling projects for a variety of products. This includes ensuring that all labeling requirements are met, that the labeling is accurate and up-to-date, and that the labeling meets all applicable regulations. Detailed Job Description The Labeling Project Manager is responsible for managing the development and implementation of labeling projects for a variety of products. This includes working with internal teams, external vendors, and regulatory agencies to ensure that all labeling requirements are met, that the labeling is accurate and up-to-date, and that the labeling meets all applicable regulations. The Labeling Project Manager will also be responsible for managing the budget and timeline of labeling projects, as well as ensuring that all labeling projects are completed on time and within budget. Job Skills Required
• Excellent project management skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects simultaneously
• Knowledge of labeling regulations and requirements
• Knowledge of labeling software and systems
• Knowledge of budgeting and financial management
Job Qualifications
• Bachelor’s degree in a related field
• 5+ years of experience in labeling project management
• Experience in the pharmaceutical or medical device industry
• Knowledge of FDA and other regulatory requirements
• Knowledge of labeling software and systems
Job Knowledge
• Knowledge of labeling regulations and requirements
• Knowledge of labeling software and systems
• Knowledge of budgeting and financial management
• Knowledge of FDA and other regulatory requirements
Job Experience
• 5+ years of experience in labeling project management
• Experience in the pharmaceutical or medical device industry
Job Responsibilities
• Manage the development and implementation of labeling projects
• Ensure that all labeling requirements are met
• Ensure that the labeling is accurate and up-to-date
• Ensure that the labeling meets all applicable regulations
• Manage the budget and timeline of labeling projects
• Ensure that all labeling projects are completed on time and within budget
• Work with internal teams, external vendors, and regulatory agencies