- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Stryker (Trenton, NJ)
- …+ Lead and mentor teams to build robust software architecture aligned with regulatory requirements. + Drive development and utilization of tools and systems that ... management. + Knowledge of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971,...of 3 days. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance,… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …SubTeam + Develops/maintains understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and ... therapeutic standard practice, compound(s) including mechanism of action and drug landscape + Applies basic scientific expertise to support initiation and execution… more
- Cardinal Health (Trenton, NJ)
- …with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …antibodies (ADA), and neutralizing antibodies (NAb) in biological samples to support drug development and regulatory filing. **Essential Functions:** * Develops, ... workflows and method development. * In-depth knowledge of global regulatory expectations ( FDA , ICH, EMA) for PK and immunogenicity testing. * Skilled… more
- Ascendis Pharma (Princeton, NJ)
- …our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially ... launch of an investigational treatment for hypoparathyroidism currently under review by the FDA . This role requires the ability to be both strategic and tactical,… more
- Ascendis Pharma (Princeton, NJ)
- …TransCon programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Cytel (Trenton, NJ)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... coding of medical terms using standardized dictionaries (eg, MedDRA, WHO Drug ). This individual brings advanced knowledge of medical terminology, clinical trial… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more