- Lilly (Indianapolis, IN)
- … regulatory requirements and Commercial GMP + Knowledge of pharmaceutical manufacturing operations. + Demonstrated coaching and mentoring skills. + Experience ... with the validated process and are compliant to cGMPs and regulatory commitments. **Responsibilities:** **Key Objectives/Deliverables:** + Serve as a liaison between… more
- Takeda Pharmaceuticals (Boston, MA)
- …(SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and ... submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post submission activities; build general and project level… more
- Sanofi Group (Morristown, NJ)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. + Advance ... full clinical study protocol. + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. + Review… more
- Lilly (Indianapolis, IN)
- …strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance , and business needs. + Provide ... technology as appropriate. + Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other … more
- AmeriHealth Caritas (Washington, DC)
- …Support the development and implementation of medical policy, including maintaining compliance with regulatory guidelines and recommended modifications to ... community, provider, health system networks, professional associations, and District regulatory agencies to advance clinical excellence and the delivery of… more
- GE HealthCare (Waukesha, WI)
- …bench and human clinical research priorities for product development, regulatory submissions, and marketing, based on intended clinical applications, business, ... and regulatory strategy + Establish and cultivate strategic academic partners...medical reviews of promotional and scientific materials to ensure compliance with applicable regulations and clinical accuracy + Provide… more
- Lilly (Indianapolis, IN)
- …process validation. + Thorough technical understanding of quality systems and regulatory requirements. + Knowledge of pharmaceutical manufacturing operations. + ... in accordance with the validated process and are compliant to cGMPs and regulatory commitments. **Key Objectives/Deliverables:** + Serve as a liaison between CMs and… more
- AT Still University (Mesa, AZ)
- …and technology. + Recruit, screen, and enroll research participants. + Ensure compliance with all regulatory activities and duties, at institutional, local, ... investigator(s) and other key stakeholders (eg, research team members, funders, regulatory bodies) on study-specific research processes. + Research study data… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to ensure that digital solutions are aligned with enterprise strategy, regulatory requirements, and patient-centric goals. You will lead demand management processes, ... Management 2.0 by refining processes, tools, and best practices. **Ensure Compliance and Architectural Alignment** : Collaborate with enterprise architects and … more
- Fairview Health Services (Wyoming, MN)
- …education, medication safety, quality assurance, customer service, process improvement and regulatory compliance . This position may also participate in education ... to department policies and pharmacy regulations. + Act as resource for pharmaceutical care to patients, partnering with interdisciplinary care team members to ensure… more