- Genmab (Plainsboro, NJ)
- …new data source and methodologies. . Contributes to submission related documents ( labeling documents, REMS/RMPs, etc) . Trains staff on signal detection activities ... experience in drug safety or related area required. . Understanding of global health authority regulations and guidances surrounding the processing, reporting 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
- J&J Family of Companies (Titusville, NJ)
- Manager, Global Labeling Product Leader - 2406208837W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, ... is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ;...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… 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
- Bausch Health (Bridgewater, NJ)
- Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, ... and values drive our collective progress and impact. **OBJECTIVES/PURPOSE OF JOB** Labeling Manager is responsible for leading labeling artwork projects for… 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
- Bristol Myers Squibb (Princeton, NJ)
- …Reviews. Align regulatory plans with commercial and development plans + Develop target labeling and co- lead the cross-functional labeling team. + Ensure ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). +… 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
- Bristol Myers Squibb (Princeton, NJ)
- …strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** + Lead safety ... develop strategy for signal evaluation and document outcome. + Lead safety labeling activities for assigned products/...to publications/ presentations. Clinical Development + Act as the global safety lead for assigned compounds in… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting programs in the ... participation in product-related teams. + Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team… more
- Merck (North Wales, PA)
- …with our alliance partner and internal cross functional team members + Support the Global Asset Lead to develop the Integrated Business Strategy by actively ... **Job Description** We have an exciting **Director** opportunity to join our global oncology marketing team focusing on co-commercialization of an Antibody Drug… more
- Pfizer (Collegeville, PA)
- …Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end ... outcomes research, RW-relevant health informatics, and biostatistics talent from global , international markets into one team to drive efficiency through… 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
- Catalent Pharma Solutions (Philadelphia, PA)
- …rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design ... for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured… more
- Sanofi Group (Bridgewater, NJ)
- …input on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position ... Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory...Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- TE Connectivity (Berwyn, PA)
- …governance, risk, and compliance processes related to a broad range of global threats, regulations, and requirements. The Data Protection Risk Manager is vital ... and related areas across TE Connectivity. **RESPONSIBILITIES:** + Develop and lead the implementation of an enterprise-wide Data Protection Risk & Governance… more
- Pfizer (Collegeville, PA)
- …Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end ... outcomes research, RW-relevant health informatics, and biostatistics talent from global , international markets into one team to drive efficiency through… more
- Sanofi Group (Bridgewater, NJ)
- …disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global ... objectives. In this role you will: + Enable the Global Regulatory Lead (GRL) to provide regulatory...Strategy (GRPS) and ensures alignment with the core product labeling for vaccines in his/her remit. + Participate in… more
