- 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
- Insmed Incorporated (NJ)
- …involving QC data or practices from external labs.Collaborate with Analytical Development, Quality Assurance , Regulatory Affairs , Supply Chain, and other ... of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for...regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high- quality responses to agency… 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** The Associate Principal Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry,… 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
- 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
- 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
- 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
