Global Labeling Compliance & Project Specialist
Fort Worth Metro Area, TX
The Global Labeling Compliance and Project Specialist is responsible for the tracking, monitoring and reporting on the global implementation of corporate agreed, safety related product information changes (Core Data Sheet- CDS amendments and updates) for products in order to achieve harmonization of Pharmaceutical Product Information. Additionally the Labeling Compliance and Project Specialist will provide support for Labeling systems and projects, as applicable.
Perform tracking of safety related changes to the CDS for RA Milestones; includes follow-up with stakeholders where relevant.
Support creation of safety label change quarterly and annual compliance reports for headquarter functions (RA-QA), Country Pharma Organizations (CPO) and relevant boards (PSB, GLC)
Identify and escalate delays and noncompliance with the implementation of safety label changes
Support and contribute to a compliance and quality culture within the framework of the Safety Label Change Implementation processes and provide assistance, as required, during audits/inspections
Provide input on Global Labeling systems and processes; including improving current processes to support Global Labeling business
Serve as business contact for HQ-Global Labeling and CPO end-users for relevant labeling systems (e.g., iMedidata, SAS program)
Provide input for preparation of manuals and training materials as appropriate for labeling systems
Fluency in English as a business language.
1-3 years of experience in the pharmaceutical industry, good working knowledge of Regulatory Affairs.
Basic knowledge of Regulatory/ specifically labeling business processes and related tools.
Basic knowledge of data analysis and reporting preferred.
Strong verbal and written communication skills.
Strong IT skills
Ability to work independently and escalate issues as needed