- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough ... GxP Quality representatives, and act as the Quality Assurance point person for all GxP...for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA… 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
- System One (Bridgewater, NJ)
- …as assigned by the Associate Director , Quality or Vice President, Quality . The Quality Assurance Senior Associate plays a key role in ... Min 3-5 Years QA Experience in Food Industry - Direct experience in Quality Assurance within food, nutraceutical, or supplement sectors. + Knowledge of US… more
- Organon & Co. (Jersey City, NJ)
- …skills. + Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and imaginative ... **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC, the Associate Principal...processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of… more
- Veterans Affairs, Veterans Health Administration (Brooklyn, NY)
- …policy and external accreditation requirements, and monitor outcomes using data-driven quality assurance processes, and implement strategies for improvement ... approach to address challenges these Veterans may experience, including medical concerns and social needs. The programs provide these...staff Strategic planning to ensure the provision of high quality services to meet the needs of the Veterans… 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
- 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
- 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)
- …assigned. + 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …+ Understands clinical trial operational complexities from study start up through enrollment, quality assurance , and study readout. + Has an active role in ... strategy) understanding the relationship to clinical trial design. + In partnership with Medical Affairs , supports development of KOL plans and engagements, and… 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
- 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
- Pfizer (New York, NY)
- …Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance . + Experience building consensus and ... of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results… 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
