What you will be doing:
Supporting the global labeling lead teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
Creates/manages FDA-required Structured Product Labeling (SPL) documents, e.g., Labeling, Bulk Drug Listing, Establishment Registration, Blanket No Change Certifications.
Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork.
Coordinates US labeling submission, approval and implementation activities through internal or client, systems and processes.
Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Fine Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.
Tracks compliance with established processes. Provides compliance data to department management, internal and external clients.
Global Labeling Tracker
Update Global Labeling Tracker upon receiving communications from relevant project leads
Follow up on status of labeling project, and update the tracker accordingly
Labeling Component Repository Tracker
Manage and Update the Tracker upon receiving new information regarding implementation and labeling samples
Labeling Implementation and Planning Meeting (LIP) tracker
Provide inputs to the LIP tracker in coordination with the GLL
Preparing and Entering Labeling Requirements for Artwork Creation (in AMS)
Identifying labeling requirements for artwork creation, liaising with the local regulatory or commercial contact.
The associate assigned for each individual Labeling Project is responsible for creating and managing Artwork Request Folder
The responsible associate should shortcut the original agency-approved labeling documents, complete an Artwork Request Form, and upload other necessary documentation for Pack Ops
The responsible associate should also ensure timely communications with Pack Ops with any updates or revisions made on the labeling documents
Structured Product Labeling
Generate, publish and submit SPL
QC labeling documents
QC of labeling documents in AMS
QC labeling documents on Trackwise by utilizing DocuProof, DocuSign, Document Compare, and other relevant tools to ensure the highest quality of labeling documents and the artwork.
Remain in timely and accurate communications with the Labeling Project Lead and CMO regarding issues and discrepancies found during QC.
Preparing labeling documents for submission and response to Agency questions
Develop structure for labeling response, and prepare draft responses where applicable to labeling questions.
QC labeling documentation prior to submission
Document approvals from Sr Management
Identifying supporting information/annotations for labeling
What you need to have:
Regulatory Labeling Specialist 1
Bachelor’s degree in relevant field of study or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
Minimum 1 year of relevant experience
Working knowledge of the scientific principles of the drug development process
Working knowledge of regulations pertaining to drug product labeling
Excellent oral and written communication skills Basic project management skills
Excellent attention to detail
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status