- PCI Pharma Services (Rockford, IL)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist oversees the company's policies and objectives ... FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position does not have any supervisory...Site Master Files. + Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior Director of ... updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating, tracking… more
- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively… more
- Rush University Medical Center (Chicago, IL)
- …and other legally protected characteristics. **Position** Clinical Research Regulatory Coordinator - Research Affairs **Location** US:IL:Chicago **Req ID** ... depending on the circumstances of each case. **Summary:** This positions provides regulatory support for multiple clinical research studies, which may involve… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …evidence generation policies, goals, and reports. + Assist in the development and submission of clinical reports to Regulatory Affairs + Provide guidance to ... Clinical / Regulatory Affairs staff on clinical strategy issues between BDPI and FDA (and other regulatory bodies). + Drive strategy for BDPI and… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a one-year contract opportunity with a leading molecular diagnostics ... **Company:** Kelly(R) Science & Clinical **Overview and Responsibilities** + The Regulatory Affairs Process Specialist will work with the SAP (ERP System)… more
- J&J Family of Companies (Irvine, CA)
- … will: + Work with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Quality & Compliance, Health Economics & ... as it is rewarding. The Director will have medical affairs responsibility in providing therapeutic and clinical ...launch and training. + Lead the support for all clinical studies - both for regulatory purposes… more
- J&J Family of Companies (Irvine, CA)
- …+ The Associate Franchise Medical Director will work with Medical Business Partner to; R&D, Clinical Affairs , Regulatory Affairs , Quality & Regulatory ... potential. At Johnson & Johnson, we all belong. The Associate Director Medical Affairs is the primary clinical /medical representative for new product development… more
- Kelly Services (Creve Coeur, MO)
- Kelly(R) Science & Clinical is seeking a ** Regulatory Affairs Support Specialist (Entry to Mid-Level)** for **6-12 month assignment** position at a client in ... field, who is eager to develop their expertise in regulatory affairs . **Key Responsibilities:** + Assist with...of the Kelly Talent Community.Why Kelly (R) Science & Clinical ? Kelly Science & Clinical is your… more
- Abbott (Lake Forest, IL)
- …is advantageous. + Prior experience in medical devices and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house ... work experience. + **Minimum 10 years** of progressive work experience in regulatory affairs or a related discipline in the in vitro diagnostics/medical device… more
- Dignity Health (Phoenix, AZ)
- …tobacco-free campus._ **Responsibilities** Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program ... trial sponsors. Responsibilities Include: + Manages all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from… more
- Beth Israel Lahey Health (Boston, MA)
- …Word, Excel, PowerPoint or Access. **Preferred Qualifications:** + 1-3 years of clinical trial regulatory affairs experience preferred. **Competencies:** ... in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth...Qualifications:** + Bachelor's degree required; Master's degree preferred in Regulatory Affairs . + 1-3 years related work… more
- Dignity Health (Phoenix, AZ)
- …A unique skill-set with high attention to detail and subject matter expertise in Clinical Research Regulatory Affairs management is essential to drive ... community we are proud_ _to be_ _a tobacco-free campus._ **Responsibilities** The Clinical Research Regulatory Project Manager position exists to support… more
- Amazon (Bellevue, WA)
- …business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs , and internal auditors. Our ... as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The… more
- Ascendis Pharma (Palo Alto, CA)
- …result interpretation. + Develops solutions to statistical and data analysis issues for clinical issues for regulatory , medical affairs , market access, and ... external meetings. + Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies and key opinion… more
- Abbott (Santa Clara, CA)
- …Degree in Life Sciences; Advanced degree(s) in biomedical science, medicine, nursing, clinical /mechanical engineering, regulatory affairs , or related fields ... project management, technical/medical/ regulatory writing experience, risk management, biomedical/ clinical research, regulatory affairs , clinical… more
- BeiGene (Emeryville, CA)
- …internally and externally in support of the Company's mission, in collaboration with Clinical Development, Regulatory Affairs , and Medical Affairs . ... and health equity strategy created in alignment with Corporate Affairs and Human Resources. As the clinical ...This role will work actively and directly with the Clinical Operations, Regulatory , Clinical Development,… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. + ... company guidelines. + Tracks, routes, and files Financial and regulatory documents in designated area. + Track clinical...approvals. + Review and approve invoices related to ongoing clinical projects. + Communicate clinical affairs… more
- Abbott (Temecula, CA)
- …from internal and external customers. + Works cross functionally with division Compliance, Clinical Science, Regulatory Affairs , Medical Affairs and ... with all on-market product performance, product performance, quality compliance, clinical science, medical information, scientific, and regulatory groups… more
- Stryker (Philadelphia, PA)
- …a technical and/or scientific discipline required + 2+ years industry experience in clinical , quality or regulatory affairs (Risk Management, Design quality, ... CERs, CEPs, PMCFRs, PMCFPs, SSCPs). + This role bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them… more
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