- Cardinal Health (Trenton, NJ)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Cytel (Trenton, NJ)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… more
- Lilly (Branchburg, NJ)
- …and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise ... stay current and relevant. + Assure adherence of applicable regulatory (ie cGXP, CFR, etc.) practices during execution of...regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg Privacy, OSHA, etc.)… more
- Teva Pharmaceuticals (Edison, NJ)
- …Certifications: + Knowledge of Current Good Manufacturing Practices ( cGMP), Food and Drug Administration ( FDA ), OSHA and related federal, state and local laws, ... acceptance testing and commissioning support, ensuring compliance with company and regulatory standards. + Collaborate with Engineering, Operations, Supply Chain and… more
- J&J Family of Companies (Raritan, NJ)
- …. Working with functional partner leadership (eg, Global Clinical Operations (GCO), Regulatory , Global Medical Safety) to achieve common goals + Presenting and/or ... responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations + Participating in formulating our… more
- Bristol Myers Squibb (Madison, NJ)
- … regulatory requirements, particularly in the pharmaceutical industry (cGMP, FDA , EMA). + Strong problem-solving, analytical, and organizational skills. + Ability ... levels, ensuring purchase orders are up to date for Drug Substance, Drug Product, and Finished Goods...with necessary stakeholders. + Support inventory risks related to regulatory or artwork changes. **Metrics and Reporting:** + Track… more
- J&J Family of Companies (Raritan, NJ)
- …Director helps to prepare relevant sections of documentation and communication for regulatory agencies and HTA agencies to provide the necessary evidence in support ... + Strong working knowledge and application of the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in...Labeling Claims" and other relevant PRO and Patient Focused Drug Development guidances and best practices is required. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …a thorough understanding of the following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485, Medical Device ... of medical products is in compliance with corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …as a general understanding of important topics including clinical trial design, drug development, regulatory decision making and public policy. + Responsible ... education programs, as well as planning around key data announcements, regulatory milestones and launch planning for late-stage pipeline candidates. + Maintain… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …as a general understanding of important topics including clinical trial design, drug development, regulatory decision making and public policy. . Responsible ... education programs, as well as planning around key data announcements, regulatory milestones and launch planning for late-stage pipeline candidates. . Maintain… more