- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions...globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety ), Research and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... Call Center, Intake and Triage, Customer Care Call Center, Product Quality /Technical Complaints, Patient Safety Organization Call Center Vendor. Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.Coordinate and ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Merck & Co. (Rahway, NJ)
- …and post-market activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's ... content is clear, accurate, and compliant.Lead the analysis and interpretation of safety data for inclusion in regulatory submissions and marketing applications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy… more
- Merck & Co. (Millsboro, DE)
- …accountable for IPT performance against site and division goals, including quality , safety , delivery, cost of goods, and budget forecasts.Translate ... leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Insmed Incorporated (NJ)
- …teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program ... for the future of science, we're in. Are you?About the Role:The Associate Director , Clinical Research Scientist will support and work predominately with the Medical… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... and ensure that all platforms (eg syringes, auto injectors, bottles, blisters) meet safety , efficacy, quality , and robust supply standards. Drive proactive risk… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory ... or fellowship in a related field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management… more
- Merck & Co. (Rahway, NJ)
- …that all solutions (eg thermal containers, package designs, new components) meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams and stakeholders to ensure that all platforms meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to facilitate… more
- Insmed Incorporated (NJ)
- …documents (ie Joint Operating Guidelines, Quality Management Plans, Safety Data Exchange Agreements).Participates in Regulatory Authority inspections and ... we're in. Are you?About the Role:Reporting to the Sr Director , Quality Assurance - Pharmacovigilance, the Manager...Quality Assurance serves as a strategic partner managing quality and regulatory compliance related to Good… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Requirements, Safety Standards, Standard ... collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety , and Facilities management to drive overall success… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful ... teams to ensure that all platforms (eg syringes, auto injectors, kits) meet safety , efficacy, quality , and robust supply standards. Develop and maintain strong… more
- Merck & Co. (Rahway, NJ)
- …for large capital projects, ensuring predictable project performance in alignment with safety , quality , cost, and schedule objectives. Manage Project Procurement ... Job Description Role Summary The Associate Director of Procurement for Capital Projects will be responsible for overseeing and managing procurement activities for a… more
- InterDent (Amboy, WA)
- …as Gentle Dental and Blue Oak Dentalare dedicated to delivering high- quality , patient-centered care through modern technology, clinical excellence, and compassionate ... health outcomes. Position Overview We are seeking a dynamic Regional Clinical Director (RCD) to provide clinical leadership and operational support to approximately… more
- AUROBINDO (Durham, NC)
- …Mentors junior analysts and leads/organizes general training and technique trainingWorks with Director , formulations team, and regulatory team to draft sections ... Pharma USA, Inc. is committed to delivering a broad portfolio of quality , affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc.… more
