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Sr. Specialist/Expert/Sr. Expert Regulatory Labeling
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
- Create and maintain global Reference Product Information/Company Core Data Sheets, based on scientific data, for mature products in co-operation with the product teams as the basis for worldwide harmonized product labeling documents
- Lead multi-discipline labeling teams, presenting labeling proposals and reaching consensus on proposals and presentation of labeling proposals to Labeling Decision Board for internal approval of proposed labeling
- Enable representatives from all major disciplines involved (e.g. Medical, GPS regulatory) to reach agreement on the best competitive labeling for the product
- Oversee and support implementation of Reference Product Information/Company Core Data Sheets into local/regional labeling documents
- Provide, upon request, analysis of competitor labeling in the relevant therapeutic area
- Update labeling for mature products, resulting in completion of internal and external approved product labeling, including Corporate, and EU CP and MRP/DCP labeling
- Participate in labeling negotiations with regulatory agencies and review local labeling for consistency with corporate labeling
- Monitor compliance of locally/regionally developed labeling documents for consistency with the Reference Product Information/Company Core Data Sheet and timely submission of label (safety) changes
- Prepare labeling that supports the safe and effective use of the product that meets the company's strategic requirements
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html