- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …comprehensive training programs that support clinical excellence, regulatory compliance, and medical affairs expertise across our global CMR organization. The ... job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs ...procedures, and industry best practices Key Area # 4 Quality Assurance & Continuous Improvement Monitor training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overnight travel. Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance , Regulatory Affairs , etc.); advanced degree ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...preferred 7+ years of experience in documentation management, quality assurance , or regulatory compliance within the… 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 Scientist is responsible for?developing… 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 or Executive Director in Organon...processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of… more
- Mount Sinai Health System (Brooklyn, NY)
- …to the Department Leadership Team and the Residency Program. + Assist the Administrative Director of Medical Affairs and Emergency Medicine to assure the ... experience. Bachelor's Degree preferred. + 3 years administrative or medical office experience required **Responsibilities** **_Roles and Responsibilities:_** +… 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
- 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
- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …or related fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in the pharmaceutical, biotech, ... (eg, FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device operations. Reporting to the Senior Director of Inspection… 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
- 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
- Pfizer (New York, NY)
- …Facilitation** + Act as the primary liaison between business units (eg, Commercial, Medical Affairs , Market Access) and technical teams (eg, Data Science, ... user stories, and acceptance criteria for AI solutions. + Collaborate with UI/UX, QA , and Solutions Architecture teams to ensure business needs are reflected in… 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
- Novo Nordisk (Plainsboro, NJ)
- …comprehensive training programs that support clinical excellence, regulatory compliance, and medical affairs expertise across our global CMR organization. The ... job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs ...industry best practices + Key Area # 4 + Quality Assurance & Continuous Improvement + Monitor… 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
- City of New York (New York, NY)
- …role provides essential cross-cutting support for non-clinical functions within the Office of Medical Affairs . You will gain broad exposure by assisting teams ... as needed. - Support the MDR-TB coordination team: Assist with data extraction and quality assurance checks; serve as a reliable point of contact for responding… more
- City of New York (New York, NY)
- …two (2) Psychiatric Nurse Practitioner for the roles below. Under the supervision of the Medical Director and of the Mental Health Director , with latitude ... to themselves and/or others in coordination with police, Emergency Medical Services (EMS) and hospital personnel. 4. Refer appropriate...8. Comply with standards of care and relevant HRA quality assurance standards, including but not limited… more
