- J&J Family of Companies (Titusville, NJ)
- …for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
- J&J Family of Companies (Titusville, NJ)
- …matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance , quality ... science, digital health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related… more
- J&J Family of Companies (Titusville, NJ)
- …for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …vendor risk assessments, Quality Issue Management for Pharmacovigilance and Medical Affairs vendors. + Interfaces with key internal business stakeholders ... our high-performing team that supports Clinical Development, Pharmacovigilance & Medical Affairs programs at Gilead. In this...affairs vendors + Has effectively operated within Clinical Quality Assurance or similar function in a… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and compliance advisor to all global R&D functions (which includes Global Medical Affairs , Global Pharmacovigilance, and Global Health Economics Values and ... Outcomes) as well as the US Medical Affairs function. In this strategic capacity,...Pharmacovigilance, Health Economics & Outcomes Research, Generics, and Clinical Quality Assurance . + Develop, maintain and deliver… more
- J&J Family of Companies (Titusville, NJ)
- …Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies ... unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
- J&J Family of Companies (Titusville, NJ)
- …interactions of the SRP include project management, finance, legal, quality assurance & compliance, clinical supplies, regulatory affairs , data management, ... medical writing, biostatistics, global safety, global medical affairs , clinical operations, and other scientific and business-related disciplines. The SRP may… more
- Ascendis Pharma (Princeton, NJ)
- …Safety. + Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs , Commercial Organizations and PV staff as applicable. + ... provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance , and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability for Results -** Stay focused… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cost reduction where appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance , Regulatory Affairs , and Operations to align ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...+ Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT function in interactions… more