- Teva Pharmaceuticals (Parsippany, NJ)
- …and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not ... local and major international authorities like EMA and US FDA for products and process, + High level of...EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of chemical/pharmaceutical production operations/… more
- Oracle (Trenton, NJ)
- …role plays a critical part in ensuring the reliability, security, and regulatory compliance of medical devices, mobile devices, printers, and other equipment ... support and maintenance procedures align with healthcare regulations (eg, HIPAA, FDA , and other applicable standards) and organizational security/privacy policies. +… more
- J&J Family of Companies (Titusville, NJ)
- …to the end user. Support tech transfer activities through process validation and regulatory approval. + Author, approve or support the writing of URSs (User ... of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead ... input into clinical development documentation, scientific publications and presentations and regulatory documentation. + May participate in or lead special projects… more
- J&J Family of Companies (Titusville, NJ)
- …to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement ... of responsibility * Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies… more
- Taiho Oncology (Princeton, NJ)
- …as Business partners). + Effectively manage to ensure compliance with regulatory submissions and internal timelines. + Participate in audit preparedness activities ... and serves as subject matter expert during regulatory inspections in collaboration with team members. + Maintain...plus. + Expertise in relevant food and drug administration ( FDA ), European union (EU) and international conference on Harmonization… 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
- Terumo Medical Corporation (Somerset, NJ)
- …/ 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and ... strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety throughout the study lifecycle..../ 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations * Strong auditing and risk management skills.… more
- Terumo Medical Corporation (Somerset, NJ)
- …**Job Details/Responsibilities** + Works with other Medical Groups, Marketing, Sales, Regulatory and Compliance to assure business objectives are aligned and ... market, industry, competitor, and health care compliance, legal, and regulatory knowledge. Understands the external marketplace including competitor offerings and… more
- J&J Family of Companies (Titusville, NJ)
- …to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement ... * Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies and… more