Director, Global Labeling Strategy, New Product Portfolio
Join Bristol Myers Squibb as a Director, Global Labeling Strategy, New Product Portfolio.
Role Overview: This position oversees the development of labeling content (TPL, CCDS, USPI, and EU SmPC) and strategies for early assets, ensuring effective and compliant labeling documents from development through regulatory approval, supporting global market differentiation.
Key Responsibilities:
1. Global Labeling Strategy & Execution:
* Lead labeling strategy development during clinical development, regulatory submissions, and product launch.
* Develop competitive target product labeling using insights from market analysis and regulatory standards.
* Establish and communicate labeling frameworks aligned with market needs and regulatory standards.
* Manage internal alignment and proactively address labeling risks.
* Respond to labeling inquiries from health authorities and during inspections.
1. Operational Oversight:
* Conduct risk assessments and ensure labeling readiness.
* Create and negotiate labeling documents with health authorities.
* Coordinate cross-functional labeling activities to optimize speed and quality.
2. Stakeholder Management:
* Lead the Labeling Strategy Team (LST).
* Build relationships with internal teams to ensure seamless execution.
* Manage labeling review and approval processes.
3. Policy & Knowledge Sharing:
* Influence regulatory policy related to labeling.
* Mentor team members and lead initiatives for process improvements and innovation.
Compensation & Benefits: The starting salary ranges from $182,000 to $228,000, plus incentives and stock options. Benefits include medical, dental, vision, wellness programs, 401(K), paid holidays, vacation, parental and caregiver leave, tuition reimbursement, and more.
Work Environment: Flexible options based on role, including onsite, hybrid, or remote work, with accommodations available for disabilities. Vaccination against Covid-19 is strongly recommended.
Qualifications & Requirements: Proven experience in labeling strategy, regulatory affairs, or related fields within the pharmaceutical industry. Leadership skills and ability to manage cross-functional teams are essential.
Join Us: Be part of a culture that values diversity, innovation, and making a difference in patients' lives. Apply even if your experience isn't a perfect match; your unique talents could be the perfect fit.
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