Back to jobsLabel Development:
Labeling Tools:
Regulatory Support:
Skills and Experience:
Job Description
- Represent RO Labeling during NNI - Local Labeling Committee (LLC) and HQ – Product Labeling Council meetings and communications, ensuring accurate reconciliation and incorporation of comments into draft labels in collaboration with responsible TA personnel
- Drive the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
- Ensures additional filing requirements are completed for approved content of labeling to include SPL drug Listing, FDA 2253s and Puerto Rico Registrations
- Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups
- Utilizing FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with agencies to resolve any issues
- Act as a resource for colleagues, providing guidance, training, and mentorship, while contributing to the development of new concepts, standards, and techniques in labeling operations
- Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
- Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations
- Actively participate in industry meetings and conferences to stay abreast of regulatory developments and industry trends
- Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations
- Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel
- Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices
- Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes