- 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
- 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 ... consider applications from any interested applicants.** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC, the Associate… 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
- 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)
- …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
- 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
- PNC (New York, NY)
- …and performs defined procedures, analyses and report preparation.Performs data aggregation, quality assurance reporting, and routine transactions as a part ... contribute to the company's success. As an Asset Liability Management Associate Director within PNC's Liquidity & Capital Planning Funding Desk organization, you… 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
- City of New York (New York, NY)
- …Racial Equity and Social Justice Initiatives, STI, and Viral Hepatitis. Reporting to the Quality Assurance ( QA ) Coordinator, you will learn and apply ... communicable disease control principles including interviewing, contact follow-up, medical record abstraction, and epidemiologic record systems maintenance. You will… more
- American Express (New York, NY)
- …high-risk areas signal need for intervention and focus), including conducting independent quality assurance and vertical process testing + Compile thematic risk ... improvements + Identifying areas of risk for intervention, including conducting independent quality assurance and process testing + Reviewing thematic risk… 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
