- 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
- Sumitomo Pharma (Trenton, NJ)
- …using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle ... 21 Checks + Knowledge about CDISC and Regulatory Guidelines + Demonstrate coaching skill to mentor Statistical...to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and supply chain related vendors and service providers. Support and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc. ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- J&J Family of Companies (Titusville, NJ)
- …end user. Support tech transfer activities through process validation and regulatory approval. + Ownership for clean utility systems throughout project execution, ... of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies… 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
- Bristol Myers Squibb (Madison, NJ)
- …strategies. + Support Global Product Teams (GPT) on clinical development and regulatory activities through robust evidence generation to optimize patient access. + ... + Strong knowledge of pharmaceutical development and product promotional guidelines (eg FDA Consistent with Label guidance, FDAMA 114). + Limited domestic and… more