- 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
- J&J Family of Companies (Titusville, NJ)
- …TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies ... development partners, and other key stakeholders + Responsible for review of medical publications emerging from the Team and its affiliates + Accountable for… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …MTP internal colleagues in various functions ( Quality Assurance , Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug Safety, Finance, ... + Collaborates effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance , Regulatory Affairs , Finance, etc. of Mitsubishi… more
- Ascendis Pharma (Princeton, NJ)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits. . Functions as a patient ... safety advisor to Ascendis Clinical Development Organizations, Medical Affairs , Commercial Organizations and PV staff. . Provides pharmacovigilance expertise to… more
- Integra LifeSciences (Plainsboro, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA , and Clinical & Regulatory Affairs . + Project Management ... set new standards of care. **SUMMARY** This position reports to the Director , Manufacturing Operations & Engineering and is responsible for manufacturing engineering… more
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