- Penn Medicine (Plainsboro, NJ)
- …checks as assigned. 15. Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, ... etc) 16. Flexible and readily adopts new processes and engages in practice operation changes. 17. Performs duties in accordance with Penn Medicine and entity values, policies, and procedures 18. Other duties as assigned to support the unit, department, entity,… more
- BD (Becton, Dickinson and Company) (Branchburg, NJ)
- …services in accordance with client requirements, timelines, company SOPs, and regulatory standards. The Senior Project Manager will lead all activities around ... + Experience working within quality systems in a highly-regulated environment ( FDA , DEA, ISO) + Strong problem-solving, prioritization, and multitasking skills;… more
- Taiho Oncology (Princeton, NJ)
- …Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator, as applicable. + ... and utilizes good judgment. + Knowledge of, and competence in, application of FDA /GCP/ICH guidelines. + The incumbent in this position may be required to perform… more
- System One (Lindenwold, NJ)
- …PRN role ensures all research activities are performed in compliance with regulatory , ethical, and scientific standards and that subject safety is prioritized at ... a PI or Sub-Investigator. + In-depth knowledge of respiratory therapeutics, FDA , and ICH-GCP standards. + Strong leadership, organizational, and communication… more
- Bausch + Lomb (Bridgewater, NJ)
- …and improve decision-making. Oversee technology support for GxP Clinical and regulatory compliance in the context of global operations. Support the implementation ... cloud transformation. Experience managing compliance with global health authorities ( FDA , EMA, PMDA, etc.). Demonstrated success leading global, cross-functional… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …laboratory practices (GLP) consistent with product development objectives and regulatory guidelines. + Maintain good documentation practices (GDP) when generating ... tasks/projects simultaneously + Understanding of industry standards and regulations (ISO, FDA , OSHA, ASTM) desirable At BD, we prioritize on-site collaboration… more
- AbbVie (Branchburg, NJ)
- …their work activities in compliance with AbbVie internal requirements and applicable regulatory requirements, including 21 CFR 820, ISO 13485 and ISO 14971. AbbVie ... + Ability to learn and function in a controlled environment regulated by FDA GMPs and handle confidential data. + Medical device and/or combination product… more
- Reckitt (Belle Mead, NJ)
- …**Your responsibilities** + Lead cross-functional teams across Marketing, R&D, Regulatory Affairs, Sourcing, Planning, Sales, Quality, Manufacturing, and Customer ... roll up final costing and validate margin targets + Ensure all documentation meets FDA and cGMP standards for OTC and dietary supplement products + Track and report… more
- Lundbeck (Toms River, NJ)
- …**Pharmaceutical Environment/Compliance** - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies ... and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts… more
- Integra LifeSciences (Plainsboro, NJ)
- …must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The ... + Change control, non-conformance and CAPA support. + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **QUALIFICATIONS**… more