- Sanofi Group (Morristown, NJ)
- …Our Medical function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to support patients' needs. ... You** **Education:** Advanced degree in a scientific discipline (MD, PhD or PharmD) **Experience:** + Significant immunology experience required (Gastroenterology… more
- SMBC (Jersey City, NJ)
- …assurance responsibilities. Provide support in preparation of management reports and regulatory presentation. + Conduct or lead internal audits and issue validation ... at all levels within the organization. + Understanding of applicable regulatory standards (including Model Risk (SR 11-7)). **Qualifications and Skills** +… more
- AbbVie (Florham Park, NJ)
- …and innovations in drug development spanning trial design, monitoring and regulatory submissions, as well as post-marketing access. As a Senior Manager, ... to advance medicines to our patients. Role Responsibilities: + Support regulatory submission and product life-cycle management strategy planning and implementation.… more
- J&J Family of Companies (Titusville, NJ)
- …using critical relationships across US Medical Affairs, Global Medical Affairs, R&D, Regulatory , RW V&E (HECOR), CIS, CAC, JSA, Commercial, and others. He/she will ... Supports multi-channel approach of dissemination as well. + Supports Regulatory related activities such as the development of product...+ MD (Psychiatrist or Neuropsychiatrist) strongly preferred; may consider PhD , PharmD or NP + A minimum of 10… more
- Merck (Rahway, NJ)
- …transfer using immunoassay techniques. + Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs ... deadlines. + Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications. + Experience… more
- Merck (Rahway, NJ)
- …stages of clinical development, as well as process characterization and regulatory filings for successful commercialization. + Improve upstream processes by ... and problem-solving skills. + Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference… more
- Burns & McDonnell (Morristown, NJ)
- …and economic dispatch associated with congestion management scenarios. + Evaluates regulatory conditions and risks by applying NERC, FERC, and Regional requirements, ... assessments that evaluate impacts associated with rules implemented by regulatory agencies. + Develops and conducts detailed financial analysis...may be substituted for 1 year of experience. + PhD in Engineering may be substituted for 2 years… more
- J&J Family of Companies (Raritan, NJ)
- …plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today ... source documentation and filing sections to support product lifecycle and regulatory submissions + Create, maintain, and upgrade product technical knowledge as… more
- J&J Family of Companies (Titusville, NJ)
- …trial data, observational databases, and literature reviews to support regulatory agency interactions. + Independently create study protocols, analysis plans, ... matter knowledge in oncology, Immunology or Neuroscience + Experience in regulatory -grade evidence, communicating and responding to agency reviews and comments… more
- Sanofi Group (Morristown, NJ)
- …Regulators; + You will drive the effective closure of action plans originating from regulatory inspections and internal audits **About You** + Master or PhD in ... regulations and shape Healthcare ecosystem. + Ability to translate how the regulatory , societal and technological changes in collecting and processing personal data… more