- Merck (Trenton, NJ)
- …Description** **Brief Description** **of** **Position** The Imaging Lead (Sr. Principal Scientist ) works with Clinical Imaging Scientists to support clinical trial ... aspects of the use of imaging, and oversees the work of the Clinical Imaging Scientist to ensure that timelines and deliverables are met and of high quality. The… more
- System One (Park Ridge, NJ)
- …direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through ... testing when necessary. Your expertise will directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare… more
- Merck (Rahway, NJ)
- …and close-out activities + Upon invoicing, verify project deliverables with initiating scientist or manager and document status in audit-compliant manner, prior to ... working relationships with external stakeholders (eg CROs, academic institutions, regulatory agencies, in-sourced scientific services suppliers) as defined to… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Sanofi Group (Morristown, NJ)
- …The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate. ... Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the...statistics, CMC, IA **Basic Qualifications:** + Medical doctor or doctor/ scientist + More than 5 years of clinical or… more
- Bristol Myers Squibb (Princeton, NJ)
- …programs. Key responsibilities of this role are to act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports ... on translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to… more
- Bristol Myers Squibb (Madison, NJ)
- …data to support development + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical ... lifecycle + Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines) +… more
- Sanofi Group (Morristown, NJ)
- …new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development ... + The Senior COA Lead actively participates in the regulatory and commercial dynamic specific to TA, defines and...direct accountability of some assets with support of COA scientist . + Expertise: The Senior COA Lead delivers senior… more
- City National Bank (Jersey City, NJ)
- …audit methodology and taking into consideration industry development, emerging risks, and regulatory changes and expectations. WHAT WILL YOU DO? * Audit and ... Gathers and evaluates information received from business units and other external/ regulatory sources. Ability to multi-task and work in a dynamically changing… more
- Bristol Myers Squibb (Madison, NJ)
- …Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management ... disease area and relevant science in order to meet regulatory and disease strategy targets + Provides oversight and...the literature + Keep s abreast of development and regulatory issues related to other competitive or relevant compounds… more