Review and approve all Product development documents, Master Formula, Batch Manufacturing records, Validation protocols and reports.
August 24, 2019
Participate in the revision of the annual application review guide and publications (Common Application, Slate application, etc), assisting to direct efforts of both colleagues within admissions and those from other departments such as faculty.
August 25, 2019
Assist in development endeavors including meetings with potential donors, recruiting new supporters through personal contacts, and working with development staff on program narrative for grants and other fund-raising responsibilities including the annual gala, the Bear Affair.
August 30, 2019
Management of Deviation Management & CAPA systems, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation) the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action and closure of the quality system records, and their effectiveness.
September 06, 2019
Demonstrated cultural fluency with all constituencies including students, families, and college admission professionals from a range of diverse ethnic and socioeconomic backgrounds.
September 06, 2019
Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements.
September 06, 2019
Lead in market access collaboration and align with all market access functions and customer segments including national and regional Payor account teams, patient services and field reimbursement managers, health economics and outcomes research, , pricing and contracting center of excellence, customer marketing center of excellence, market access insights & analytics, , finance, etc.
September 06, 2019
Creates an innovative environment where strong professional practice flourishes and the mission, vision and values promote positive patient outcomes believed to be important for the organization.
September 06, 2019
Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
September 06, 2019
Required travel would be increased (up to 30%) for a remote-based employee attributable to travel to the headquarter office for job-related responsibilities.
September 06, 2019
