Job Description

Job Title: International Regulatory Labelling Lead
Location: Remote
Duration: 12 months:We are seeking a Contractor Global Labeling Product Leader (GLPL) to support Pharma products in Janssen R&D within Global Labeling. This role involves the development of target labeling, labeling for New Molecular Entities (NMEs), and managing updates to Company Core Data Sheets (CCDSs), Centralized/MRP European Union Prescribing Information (EUPIs), and United States Prescribing Information (USPIs) in accordance with Global Labeling Center of Excellence (GL CoE) and Global Regulatory Affairs (GRA) end-to-end labeling processes. Training on systems and business processes will be provided.Responsibilities:

• Facilitate labeling negotiations with Health Authorities for EUPI and USPI for assigned products.
• Facilitate Labeling Working Group (LWG) review and Labeling Committee (LC) endorsement of labeling documents.
• Prepare and finalize submission-ready EUPI and USPI.
• Process Local Labeling Deviation requests for assigned products for ex-US and ex-EU markets, including facilitating LWG review and LC.
• Prepare updates to CCDS, EUPI, and USPI for products in additional therapeutic areas, including facilitating LWG review and LC endorsement of the CCDS and finalizing/releasing the CCDS.

• Minimum of a Bachelor\'s degree in a scientific discipline. An advanced degree (MS, PharmD, PhD, or MD) is desirable.
• At least 6 years of experience in the pharmaceutical industry or a health authority, with at least 5 years in regulatory affairs focusing on product labeling (prescribing and patient information).
• Experience in 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 liaising with subject matter experts and regulatory professionals.

• Expert Text Authoring: Proficiency in authoring text for inclusion in CCDSs, EUPIs, and USPIs, including drafting text based on scientific source data, supporting rationale, regulatory requirements, standards, and templates.
• Regulatory Expertise: Strong understanding of regulatory requirements and standards for pharmaceutical labeling.
• Document Management: Experience working in a Documentum-based document management system.
• Advanced Microsoft Word: Exceptional skills in Microsoft Word, with proficiency in formatting, templates, and document automation.
• Communication: Strong verbal and written communication skills, with the ability to liaise effectively with subject matter experts and regulatory professionals.
• Project Management: Excellent project management skills, with the ability to manage multiple labeling projects simultaneously.
• Basic Microsoft Office: Basic skills in Excel and PowerPoint.
• Strong verbal and written communication skills.

Intellectt