This client is a growing pharma consulting firm which provides clinical, regulatory, and commercial support to a variety of pharmaceutical companies. They are seeking a Global Labeling Strategist (Associate Director or Director Level) who can lead the preparation and review of Labeling for one of their key global pharmaceutical clients. You will develop and maintain Target Product Profiles and Company Core Data Sheets while supporting Health Authority interactions. This company offers a competitive salary, a comprehensive benefits package, and the ability to work from home.
- Lead the preparation, review, and update of content for the development and maintenance of labeling and labeling components for a portfolio of pharmaceutical products.
- Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada).
- Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
- Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies.
- Assess competitor labeling to understand precedents & opportunities for Health Authority discussions.
- Support global Health Authority interaction strategy to discuss key labeling elements.
- Assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
- Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval.
- Contribute to the continuous improvement of the end-to-end labeling process
- Bachelor degree in a scientific field required. Advanced degree (PhD/MS/DVM/MD/Pharm D) preferred.
- Five or more years of experience in US Labeling for pharmaceutical drugs or biologics.
- Solid understanding of global labeling regulatory requirements and industry practices.
- Prior experience developing and maintaining CCDS and TPPs.
- Experience in Labeling for NDAs, BLAs or MAAs.
- Excellent understanding of medical concepts and terminology.
- Strong written and oral communication skills
- Strong computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems.
- Action oriented, customer focused, ability to manage workloads, set priorities, and ability to build effective teams.
- Must be able to deal with ambiguity, be creative and be comfortable working with multi-functional teams.