- Fujifilm (Trenton, NJ)
- …measurement/data mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM ... customization, and electronic delivery of technical clinical tools and supplements. + Compliance with respect to all applicable requirements of the company's … more
- Merck (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance ... improve systems and processes. + Attends and actively participates in safety, quality , and process improvement initiatives to enhance flexibility, efficiency, and … more
- Bristol Myers Squibb (Summit, NJ)
- …Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards. + Independent ownership of all lifecycle ... site customers while promoting a positive learning, team environment. + Author quality procedures and training documents. + Deliver training on procedures and best… more
- Terumo Medical Corporation (Somerset, NJ)
- …support Market Intelligence goals. + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Burns & McDonnell (Morristown, NJ)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... experience to complex projects, and find's/develops non-standard design solutions. + Quality review production drawings for a variety of projects and project-related… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory ... Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage… more
- Sumitomo Pharma (Trenton, NJ)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
- Bristol Myers Squibb (Summit, NJ)
- …plans for hazardous materials, potent compounds, and high-containment processes. + Ensure compliance with OSHA, ACGIH, NIOSH, FDA , and other applicable health ... is critical in ensuring workplace safety, employee health protection, and compliance with regulatory standards. The ideal candidate will have comprehensive… more
- Sumitomo Pharma (Trenton, NJ)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
- Ascendis Pharma (Princeton, NJ)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits. . Functions as a patient ... Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local… more