- Sanofi Group (Morristown, NJ)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... The **Development Scientific Director** (DSD) is **a key scientific lead in the Development of R&D programs** . The...deliver development strategy and prepare/assist with regulatory bodies interaction + Provide clinical scientific expertise in… more
- Parexel (Trenton, NJ)
- … drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure ... while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient… more
- Sanofi Group (Morristown, NJ)
- …forums and present best practices to Super Users. + Develop talent and lead workstreams across Regulatory , Digital, and Data Governance. **Team-Specific Scope** ... capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead… more
- Sanofi Group (Morristown, NJ)
- …or advisory boards + Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering committees, benefit-risk ... possible for millions. The Senior Clinical Research Director (CRD) is an **expert clinical lead for one or several indications in the Development of an R&D program**… more
- Merck (Rahway, NJ)
- …support for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with Clinical, Regulatory , Statistical Programming, Data ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Bristol Myers Squibb (Princeton, NJ)
- …based on a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance ... providing expert guidance on the interpretation and application of global regulatory requirements, as required. * Develop...opportunities to enhance and improve the GROe process. * Lead or participate in sharing best practices and lessons… more
- Sanofi Group (Morristown, NJ)
- … global operations + Integrate GxP, SOX, and pharmaceutical regulatory requirements into all technology practices **What You Bring** **Required Experience** ... governance + Site Reliability Engineering with observability platform implementation + Global technology operations across distributed teams and regulatory … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH). **Compliance & Risk Management** ... executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the organization. The… more
- Merck (Rahway, NJ)
- …identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO ... regulatory , company, and customer requirements. **Principal Responsibilities** + Lead /Support continuous improvement initiatives for design control and risk… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with the CNS Medical BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial) to ensure ... relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure… more