Global Labeling Product Leader

Sunrise System Inc. is currently looking for Global Labeling Product Leader, Remote with one of our top client.

Job Title: Global Labeling Product Leader

Location: Remote

Duration: 6 months

Position Type: Hourly contract Position (W2 only)

100% REMOTE

Summary Of Role

• Contractor Global Labeling Product Leader (GLPL) to support Pharma products in Janssen R&D, within Global Labeling.
• Responsibilities include the development of target labeling, and 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, and CMC revisions), including facilitating LWG review and LC endorsement of the CCDS and finalizing/releasing the CCDS.

Contact

Satya | Sr. Delivery Manager
Direct: |Email: