- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... with the Nephrology & Immunology BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …internal Standard Operating Procedures (SOPs), Good Publication Practices (GPP), and global regulatory guidelines **Medical Information Content Generation** + ... lexicon, accurately reflects clinical trial data, and maintains consistency across global materials + Maintain content repositories and ensure version control and… more
- Astellas Pharma (Northbrook, IL)
- …and interfaces with Drug Discovery through Marketing. + Direct experience leading global regulatory marketing authorization submissions and defense of those ... Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory , biostatistics, medical affairs, Health Economics, commercial perspectives into… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …or business excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness ... leading, and optimizing one or more prioritized CoEs within the Global Quality Operations organization-such as Inspection Readiness, Audit Effectiveness, or other… more
- Astellas Pharma (Northbrook, IL)
- …+ Solid understanding of regulatory interactions with the FDA and other global regulatory agencies. + Ability to influence and deliver results in a ... remote work are encouraged to apply. **Purpose and Scope:** + Provide global vision and strategic direction for establishing and validating clinical bioanalytical… more
- AbbVie (North Chicago, IL)
- …development, quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. + Ability to ... process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing Sites. Responsibilities:… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/ global regulatory requirements + Partner with Legal, Regulatory , ... is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and… more
- Oracle (Springfield, IL)
- …renewal. + Ensure all hardware and processes adhere to company and global regulatory requirements; maintain audit readiness through documentation and system ... **Job Description** Oracle's Global Physical Security (GPS) Systems Team is responsible...(GPS) Systems Team is responsible for securing the corporation's global datacenter and facility footprint through advanced Physical Access… more
- AbbVie (North Chicago, IL)
- …and integration of novel technologies into AbbVie's clinical trials; and providing global regulatory advice relating to AbbVie's pipeline programs. Corporate ... Legal Academy Work on a wide range of clinical-trial related legal and regulatory matters in support of AbbVie's therapeutic pipeline. Provides support for AbbVie's … more
- Wolters Kluwer (Chicago, IL)
- …enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more