- Legend Biotech USA, Inc. (Raritan, NJ)
- …and handle corrective and preventative action recordsSupports internal and regulatory auditsRequirementsA minimum of a Bachelor's degree or higherA minimum ... Biology, Biochemistry, Microbiology, Chemistry or related fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality Control document… more
- Merck & Co. (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- ... and implementation of corrective/preventative actions.-Preferred Experience and Skills:Familiarity with regulatory requirements and Good Documentation Practices (GDP).-Experience with some… more
- Genmab (NJ)
- …study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality ... least 6-8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency Proficient in SAS programming, 6-8 years experience. Practical knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Proactively develops and sustains strong relationships with local/regional/national regulatory authorities.Analyzes regulatory authorities' programs and ... salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. more
- Tris Pharma (Monmouth Junction, NJ)
- …and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance ... with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …development, and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing building, ... infrastructure, equipment, and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key member of the… more
- Eisai, Inc (Nutley, NJ)
- …design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the development of Clinical Protocols to meet CDP ... to safety and efficacy.Contributes to Clinical Pharmacology expertise and content to regulatory documents (eg briefing books, INDs, NDAs etc.) and represent Clinical… more
- Christus Health (Euless, TX)
- …audits of pharmacy operations, including compliance with system initiatives, regulatory compliance, associate engagement and talent management. Coordinates with ... standards (Optix). Coordinate and lead system strategies to manage industry drug shortages, including development of system policies, guidance documents, and tools.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …regional/global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work with outsourcing/procurement ... preferred.Knowledgeable in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and… more
