- J&J Family of Companies (Irvine, CA)
- …assigned project budgets to ensure adherence to business plans; . Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive ... support of the clinical and regulatory strategy; . May serve as the clinical representative on a New Product Development team; . May assist with the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and regulations governing medical functions within industry activities and medical regulatory process, including clinical research, study design, and good ... leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- University of Miami (Miami, FL)
- … regulatory bodies. Knows the contents and maintenance of study-specific clinical research regulatory binders. Maintains requisite skills and mandatory ... SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 1 for the UHealth medical campus...side effects of treatment to the Investigator and ensures Regulatory is provided accurate information to report to IRB.… more
- AbbVie (South San Francisco, CA)
- … Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug ... of all AbbVie projects along with CLINICAL PHARMACOLOGY management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates … more
- University of Colorado (Aurora, CO)
- …with institutional, federal, and sponsor guidelines** **Examples of Duties Performed** ** Regulatory - 40%** + Submit clinical trial protocols with applicable ... basis. **Preferred Qualifications:** + Experience in industry and/or PI initiated sponsored clinical research trials. + Regulatory experience + HIPAA and human… more
- Penn Medicine (Philadelphia, PA)
- …on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety outcomes. Develops, maintains, and ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Penn Medicine (Radnor, PA)
- …departments/entities, academic involvement (research initiatives, resident program), special clinical programs, regulatory requirements, support of external ... the Nursing Professional Development team. + Ensures staff are compliant with clinical competencies and mandatory trainings. + Regulatory Compliance: + Assists… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- … clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
- Penn Medicine (Philadelphia, PA)
- …the Director, and members of the PTI leadership team to support clinical , quality, regulatory compliance, information systems, fiscal, and research goals ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Principal for a 12-month contract opportunity with a leading molecular diagnostics company. If you ... Type:** 12-month contract **Pay rate:** $50-63/hour **Company:** Kelly(R) Science & Clinical **Overview** The Regulatory Affairs Principal serves as RA… more
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