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
You already suscribed to this job 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 Project Coordinator II at Insight Global

Labeling Project Coordinator II

Insight Global Santa Monica, CA Full-Time
Apply Now

Create Job Alert.

Get similar jobs sent to your email

An employer is seeking a Clinical Lebeling Coordinator for one of our largest biopharma clients sitting in Santa Monica. This individual is expected to be a hardworking leader that encourages teams while providing technical expertise in a dynamic pharamceutical clinical labeling environment. He or she will work collaboratively with other members of Clinical Labeling, Quality, Clinical Operations, Package Engineering, Supply Chain, Regulatory and Project Management staff to meet project deliverables.

Specific Job Requirements:
  • Responsible for processing clinical labeling documents and completing activities associated with multiple clinical development programs. These include but are not limited to label generation and approval per regulatory guidelines.
Interacts with Kite internal cross-functional teams to provide input into labeling options
  • Engages the clinical labeling group to meet company goals including department improvement projects
  • Works closely with ancillary groups to process and approve GMP documents
  • Authors and reviews documents to ensure GMP compliance
  • Responsible for change control task closures and preliminary assessments
To learn more about how we collect, keep, and process your private information, please review Insight Global Privacy Policy: [ Link removed ] - Click here to apply to Labeling Project Coordinator II
  • Project and document management experience
  • Experience with Change Control
  • Able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
  • Ability to write clear, concise and error-free documents.
  • Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action.
  • Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13.
  • Prior experience with clinical labeling, including the technical aspects of label design, is preferred
  • Requires a Bachelor's degree and a minimum 2 years of relevant industry experience preferably in clinical labeling



Recommended skills

Certified Global Meeting Planner
Good Manufacturing Practices
Document Management Systems
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: LAX-418295

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.