Global Labeling Product Lead

Title: Global Labeling Product Leader

Location: Fully remote with an expectation to work in the EST hours

Duration: 6 months contract with possible extension.

Summary Of Role

• Contractor Global Labeling Product Leader (GLPL) to support Pharma products in the client s R&D, within Global Labeling.
• Responsibilities include development of target labeling, managing the development of updates to Company Core Data Sheets (CCDSs), Centralized/MRP EUPIs, and USPIs in accordance with GL CoE and GRA end-to-end labeling processes. System and business process training will be provided to the Contractor.

Qualifications, Experience and Skills

• Minimum of Bachelor's degree in a scientific discipline. Advanced degree (MS, PharmD, PhD, or MD) desirable.
• At least 6 years' experience in the pharmaceutical industry or health authority, with at least 5 years' experience in regulatory affairs with direct experience associated with product labeling (prescribing and patient information). Product labeling experience should include authoring text for inclusion in CCDSs, EUPIs, and USPIs, including drafting text based on scientific source data, supporting rationale, regulatory requirements, standards, and templates, and liaison with subject matter experts and regulatory professionals.
• Advanced Microsoft Word skills. Experience working in a Documentum-based document management system. Basic Excel and PowerPoint skills.
• Excellent project management, verbal, and written communication skills.

Responsibilities

• Facilitation of Labeling Negotiations with Health Authorities for EUPI and USPI for assigned product(s); facilitating Labeling Working Group (LWG) review and Labeling Committee (LC) endorsement of labeling documents; preparation and finalization of submission ready EUPI and USPI.
• Processing Local Labeling Deviation requests for assigned products for ex-US and ex-EU markets, including facilitating LWG review and LC.
• Preparing updates to the CCDS, EUPI and USPI for products in additional therapeutic areas (for new indications, safety updates, CMC revisions), including facilitating LWG review and LC endorsement of the CCDS and finalizing/releasing the CCDS.