- University of Miami (Miami, FL)
- …of general and study specific regulatory related processes with institutional SOPs, FDA , NIH, and other applicable regulations. Adheres to University and unit-level ... policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: Bachelor's… more
- Cytel (Tallahassee, FL)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- Fujifilm (Tallahassee, FL)
- …+ 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. Key Performance Indicators: + Revenue and sales bookings… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …and/or Med device or other device-related experience + Demonstrated expertise in applying FDA design control requirements (21 CFR ) as applied to medical device ... software and medical device regulation (IEC-62304) **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking &… more
- University of Miami (Miami, FL)
- …modality including but not limited to: Joint Commission, AHCA, ACR, FL DOH and FDA /MQSA. + Assist with the day-to-day operations within the department. This list of ... duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. DEPARTMENT SPECIFIC FUNCTIONS For those locations that perform Bone Mineral Density exams (BMD) in the Nuclear… more
- Cardinal Health (Tallahassee, FL)
- …+ Review marketing materials related to customer services and FDA approved pharmaceuticals. + Review Business Associate Agreements, Confidentiality Agreements ... and Information Security Agreements **_Qualifications_** + 10+ years of experience preferred + Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise + Experience working with Group… more
- Sumitomo Pharma (Tallahassee, FL)
- …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
- AssistRx (Orlando, FL)
- …and regulatory frameworks relevant to patient engagement (eg, HIPAA, OIG guidance, FDA ). + Proven ability to lead cross-functional teams and influence executive ... stakeholders. COMPETENCIES: + Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. + Ethics -… more
- University of Miami (Miami, FL)
- …as per physician treatment orders.* Ensure all research activities comply with FDA and GCP guidelines. This includes maintaining regulatory documents when needed and ... ensuring site compliance with research protocols. Mandatory (current) CITI and COI training before participating in any research-related procedure.* Oversee data collection, documentation, entry, and reporting, ensuring data integrity and consistency… more
- ZOLL Medical Corporation (Leesburg, FL)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more