- Pfizer (Groton, CT)
- …(GCP) (GxP) environment. + Demonstrated understanding of pharma quality and regulatory framework . + Demonstrated in-depth experience managing multiple clinical ... strategies. You are responsible for designing strategies that align with program, protocol , and regulatory requirements, identifying and managing supply chain… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …research institutions, and internal stakeholders. By fostering collaboration and navigating regulatory pathways, you'll lead the development and implementation ... (UXR). + Lead on digital & device-facing aspects of study: protocol , usability, tech validation, training, delivery and implementation, data transfer (in liaison… more
- Quantis (Boston, MA)
- The Global Land & Agriculture Lead provides strategic direction for addressing land & agriculture related challenges for corporate clients, specifically by refining ... offerings that are grounded in latest science and business strategy. The Global Lead oversees a global team of subject matter experts and consultants who measure… more
- Stanford Health Care (Palo Alto, CA)
- …educate patients and families on the clinical trial treatments, required testing, and protocol specific visits and expectations. Serves as lead for the disease ... is accountable for the accurate conduct of their assigned cancer research protocol portfolio. Primary activities include educating the multi-disciplinary team on the… more
- Bristol Myers Squibb (Princeton, NJ)
- …Quality Councils, Enterprise Risk Committees, and overall Global Quality Risk Management Framework . + For Clinical, lead the Serious Breach Committee focused ... setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements. + Previous experience dealing with regulatory agencies in… more
- Bristol Myers Squibb (Madison, NJ)
- …the MA/HEOR Biostatistics Lead , HEOR and Market Access functions, protocol statisticians and programmers supporting the regulatory submissions, and other ... With appropriate experience, the Associate Director can take a lead role in the statistical aspects of Market Access/HEOR...statistical/clinical trials methodology and ability to apply to relevant framework + Good understanding of regulatory &… more
- TD Bank (Mount Laurel, NJ)
- …execution of the TD Business Continuity Management (BCM) program and Incident Management Protocol (IMP) for all US legal entities. BRIM is responsible for the ... incident management strategies, governance policies, standards and practices, operating framework , reporting, notification and escalation of material and significant… more
- Bristol Myers Squibb (Princeton, NJ)
- …process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. The Executive Director will work closely ... our overall Global Quality vision and strategy. **Key Responsibilities** + Lead the Clinical Quality Assurance function, providing strategic direction and oversight.… more
- Vera Therapeutics (Brisbane, CA)
- …diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered as a ... a cross-functional product development team and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …global activities and regulators. + Ensure a process is in place for routine review of regulatory documents such as IB, protocol , CSRs, IND and NDA + Ensure GLP ... strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents supporting… more
- Bristol Myers Squibb (Princeton, NJ)
- …the Risk Management and Central Monitoring TA specific team, enabling them to lead execution of the Risk Based Management Framework , enhancement of quality, ... of reliable clinical trial information for internal decision making, regulatory approval and market acceptance, and ensure a holistic...the clinical trials (Phase 1-4) in the portfolio. - Lead and manage governance for ongoing review of portfolio… more
- Stanford Health Care (Palo Alto, CA)
- …agents through the cardiopulmonary bypass circuit on prescription and/or appropriate protocol . The Perfusionist is responsible for the monitoring of blood gases ... LEVEL DESCRIPTORS The Perfusionist career ladder consists of four levels plus a lead based on management assessment of staffing needs. The distinction between levels… more
- Merck (Boston, MA)
- …with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug ... with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data + Maintain a… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Conference on Harmonization (ICH) - Good Clinical Practice (GCP) set the framework under which clinical trials are conducted. One of the Therapeutic Area ... Outlook, Word, PowerPoint, and Excel.* Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with… more
- Entergy (New Orleans, LA)
- …directly support the federal infrastructure team and support the build out compliance framework by working across the system to support Entergy including its various ... and standards. + Support for build out of compliance framework and work with teams on negotiating with DOE.... + Work directly with internal auditing for audit protocol and corporate compliance for appropriate alignment of compliance… more
- Bristol Myers Squibb (Princeton, NJ)
- …workforce is every evolving, m arkets are more complex: increased competition, regulatory , access challenges and importance of health equity along with a stronger ... standards. S/He will need to be able influence and lead the enterprise-wide marketing organizations and drive the change...to continue to develop the bespoke BMS Marketing Quotient framework that reflects the new and changing environment to… more
- Bristol Myers Squibb (Princeton, NJ)
- …works on genomics/transcriptomics strategy (assay, platform) per program requirements, protocol requirements, program biology and mechanism. Assays include but are ... platform development. + Assay design and development: Develop the framework for assay development, qualification/validation protocols and timely, well-planned… more
- Bristol Myers Squibb (Princeton, NJ)
- …investments in science and partnerships. Collaboration is integrated into our organizational framework across translational medicine and R&D. We have an exciting new ... is seeking a leader with exceptional scientific, strategic and occupational acumen to lead and develop companion diagnostics (CDx) biomarkers in support of the BMS… more
- Bristol Myers Squibb (Princeton, NJ)
- …science and partnerships. Collaboration is integrated into our organizational framework across translational medicine and R&D. **Precision Medicine:** Precision ... Precision Medicine organization. They are accountable, with the Precision Medicine Technical Lead to support BMS product Development Teams (DT) to successfully shape… more
- Pfizer (New York, NY)
- …to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, ... disease area and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans… more