- 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
- 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
- Biomat USA, Inc. (Chicago, IL)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… 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
- Bayer (Chicago, IL)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- ADM (Decatur, IL)
- …results in a timely matter. + Support and comply to all applicable FDA , GMP, USP, Biosafety, and OSHA requirements. + Follow laboratory standards and maintain ... software). + Maintain awareness and adhere to all applicable FDA , GMP, USP, Biosafety, OSHA and employer standards and...or work at the location, please notify the hiring manager . Excited about this role but don't think you… more
- Lundbeck (Deerfield, IL)
- …professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that ... disease alliances and policy groups (eg, Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence) + Highly proactive and solutions-oriented,… more
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