- Sumitomo Pharma (Trenton, NJ)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Norstella (Trenton, NJ)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- J&J Family of Companies (Raritan, NJ)
- …the early development clinical team in the timely completion, content, and quality of key development deliverables including protocols, reports and submissions to ... . Working with functional partner leadership (eg, Global Clinical Operations (GCO), Regulatory , Global Medical Safety) to achieve common goals + Presenting and/or… more
- AbbVie (Jersey City, NJ)
- …AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible ... of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and ... of action and drug landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical… more
- Penn Medicine (Plainsboro, NJ)
- …Summary: + Under the direction of a radiologist, performs high quality diagnostic computer tomography examinations using ingenuity, initiative and independent ... applicable comparison studies, and prepares documentation for interpretation. + Performs quality control testing as required. + Clean, adjust and perform routine… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;… more
- Fujifilm (Trenton, NJ)
- …consistently high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that ... with MI Project Management (PM) team to deliver high quality Synapse product solutions. + Act as primary technical...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Sanofi Group (Morristown, NJ)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues, and fraud and abuse) as well as proposed solutions to… more
- BioLife Plasma Services (Trenton, NJ)
- …program, gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality , facilities, and people ... customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee… more