- Daiichi Sankyo, Inc. (Bernards, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for ... RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for ... RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication with external Key Opinion ... generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... direction and long-term vision for the Company. The position will also lead the Medical Affairs organization which is responsible for providing impactful medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial, Medicaid and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following … more
- Bristol Myers Squibb (Princeton, NJ)
- …and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are ... This position will provide oversight of a team of Global Labeling Strategists responsible for driving ...positive working relationships across diverse teams and within a global environment. + Ability to influence and lead… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for ... RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Ascendis Pharma (Princeton, NJ)
- …of key labeling processes and infrastructure . Work closely with global labeling managers to ensure consistency and alignment Requirements . BS/BA ... global needs as required. The RA Associate Director, Labeling will be overall responsible for ensuring compliance with...for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging… more
- Bausch + Lomb (Bridgewater, NJ)
- …to labeling process, systems, tools and/or procedures. + Participates in global labeling projects, ensuring accuracy of all labeling components ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Specialist is responsible for the development and maintenance of Labeling Requirements Specification (LRS) templates and product specific content… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to ... components, randomization file and label text). + Generates internal packaging and labeling production orders in accordance with the clinical trial design and all… more
- J&J Family of Companies (Titusville, NJ)
- …may collaborate with external partners. + Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in ... Associate Director, RA Labeling Product Leader (1 of 2) - 2406187352W...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- Sanofi Group (Bridgewater, NJ)
- …expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects. + Supervise, coach, and facilitate ... **Job title: Global Regulatory Lead ** + Location: Bridgewater,...formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling … more
- Bristol Myers Squibb (Princeton, NJ)
- …strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier submissions to ... lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development… more
- J&J Family of Companies (Titusville, NJ)
- Director, Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory ... Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health Authorities globally to find the… more
- Sanofi Group (Bridgewater, NJ)
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company ... PV expertise, and understanding of international safety regulations and guidelines + Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety… more
- Bristol Myers Squibb (Princeton, NJ)
- …strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** . Lead safety ... any data source. Develop strategy for signal evaluation and document outcome. . Lead safety labeling activities for assigned products/program. Act as the Safety… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory ... Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for...responsible for the development and update of the core global dossier / collaborates with regional lead … more
