Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
Missing Translation: eu_consumer_core.job_alert.duplicate_alert
No Thanks
US
What job do you want?

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Labeling Director at Real Staffing

Labeling Director

Real Staffing Jersey City, NJ Full-Time
competitive
Apply Now

Create Job Alert.

Get similar jobs sent to your email

Title: Labeling Director

Contract Length: 12 Months

Location: Remote

Duties:

  • Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements high quality regulatory labeling documents (e.g. USPI, US annotated labeling, US medication guides, US patient labels, draft US packaging components, EU SmPC, EU PIL, CCDS, annotated CCDS). Leads processes and associated systems to ensure appropriate review and governance of US, EU and global Company Core Data Sheet documents. Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues.
  • Ensure Compliance with Core Data Sheets/Label Changes: Provides labeling development strategic plan and has broad oversight for Core Data Sheets/label changes. Manages labeling team review of US and local country labeling deviations from CCDS; reviews and approves CCDS/labeling agreements for licensing partners.
  • Ensure Compliance with Health Authority Labeling Regulations and Guidances and with DSI labeling processes: Demonstrates expert knowledge of labeling guidances. Manages compliance with labeling regulations and guidelines and with DSI processes for reviewing package inserts, cartons and labels for compliance with regulations with regard to both content and format. Ensures inserts, cartons and labels of marketed products comply with current guidelines as needed.
  • Collaboration on Global Labeling Projects: Collaborates with other members of Global Labeling team to balance workload and share expertise as dictated by filing and approval timelines across the product portfolio. Participates in labeling process development or updates.
  • Please note: this position is not for labeling artwork development or management.

Skills:

  • Experience with new product labeling development and approval, including US, EU and CCDS.
  • Ability to manage multi-functional teams and drive consensus.
  • Deep experience with labeling content development as well as compliance and quality.
  • Must be able to meet business and health authority mandated timelines.
  • Must be able to function independently but maintain frequent and timely communication with team members and management.
  • 5-9 years of labeling experience preferred.

Education:

Bachelors degree in scientific discipline preferred. Masters degree preferred.

Sthree US is acting as an Employment Business in relation to this vacancy.

 

Recommended skills

Packaging And Labeling
Datasheets
Timelines
Documentation
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: RE-33563734

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.