Global Labeling Manager – NJ
Contractor (1-3 years)
Hourly Rate: $60-$65/hr
Facilitate and lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) and Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. Functioning independently as a decision-maker on global labeling regulatory issues; and ensuring that deadlines are met. Facilitate and lead cross-functional teams including document authors to maintain and revise CCDSs, global labeling and artwork for assigned products. Follows Global Labeling archiving procedures and maintains relevant databases and document management systems for marketed products and products in development.
Utilization of regulatory expertise to review, develop and deliver high quality core/local labeling documents such as the CPI and Patient Leaflet to support submissions to the Regulatory Authorities across regions.
Support the use and development of current and new tools, technologies and processes to support global label development, submission, approval and tracking globally.
1. Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 25%
2. Provide tactical and strategic guidance to International and Regional Project Teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis. 20%
3. Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements ; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience. Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion. 20%
4. Coordinate Content of Drug & Establishment Listing SPL generation and review. 10%
5. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. Champion and/or participate in continuous improvement efforts related to business practices and tools utilized within role. 10%
6. Ensure consistency of labeling across product lines and compliance with policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensures products have most competitive labeling. 5%
7. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities 5%
8. Oversee EU and GM translations process as appropriate 5%
• Minimum BS Degree or higher in Life Science.
• 5+ years in Regulatory, R&D or related area, at least 3 years of experience in labeling or equivalent experience within the pharmaceutical industry.
• Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and Emerging Market labeling desirable.
• Experience in both local and global regulatory labeling environments.
• Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
At this level, we are looking for:
• A seasoned Labeling person with at least US and EU experience and preferably global experience and with great attention to detail
• A solid understanding of drug development process
• Strong project management and problem solving skills with ability to work under tight timelines
• Strategic thinking and negotiation skills
• Good communication skills