- Conagra Brands (Chicago, IL)
- Reporting to the Director of Engineering, as the Engineering Project Manager , Manufacturing you will oversee engineering projects, with varying levels of complexity, ... updates, and milestones to stakeholders + Ensure compliance with industry standards, USDA/ FDA regulations, and best practices. + Foster a culture of continuous… more
- AbbVie (North Chicago, IL)
- …IL; Florham Park, NJ; San Francisco, CA or Irvine, CA. The Manager , Clinical Data and Reporting Standards (CDARS) proactively participates in the development ... of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for both FDA and PMDA submissions + Consult on conformance issues for SDTM and/or ADaM… more
- US Foods (Rosemont, IL)
- …and specifications, sanitation, HACCP, FSMA, etc. + Other duties as assigned by manager **Supervision:** + Direct oversight and management of 4+ food safety and ... Must demonstrate thorough technical knowledge of Food Safety, Food Processing, FDA and USDA Regulations, Food Ingredients, Nutrition and Allergens, Crisis… more
- United Therapeutics (IL)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... collaborative and innovative where you can showcase your expertise. The Therapy Access Manager (TAM) is a customer-facing role that will be responsible for managing… more
- ZOLL Medical Corporation (Chicago, IL)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... a minimum of 1 year OR have successfully performed within a Associate Territory Manager role. Physical Demands + This position requires the employee to sit, stand,… more
- Edwards Lifesciences (Springfield, IL)
- …SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field ... monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (eg RAVE, CTMS, Veeva, & monitoring… more
- Fujifilm (Springfield, IL)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… more
- Sumitomo Pharma (Springfield, IL)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Lundbeck (Deerfield, IL)
- …managing end-to-end process of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The ... role ensures timely and accurate submission of promotional materials to the FDA 's Office of Prescription Drug Promotion (OPDP). The specialist will also coordinate… more
- US Tech Solutions (North Chicago, IL)
- …and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the ... FDA and international Competent Authorities. + In addition will...determine and document the conclusion(s). + Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure… more