Ensures that there is proper medical coverage to cover the medical monitoring safety requirements of ongoing trials during all hours of operation for early phase clinical studies.
Works with key commercial and non - commercial stakeholders continually develop requirements and proposal to meet requirements to support the Medical Affairs projects, partnerships, and initiatives in alignment with the annual operating plan.
Verify the test procedures performed, and along with the Laboratory or Medical Director and Director of Laboratory Operations (or designee) establishes the laboratory's test performance characteristics, including precision and accuracy of each test and test system.
The Manager will assist the Administrative Director in developing and managing and is accountable to the operating and capital budgets for his / her respective departments.
Provide technical supervision of the laboratory and is accessible to the laboratory personnel to provide on - site, telephone or electronic consultation.
Oversees implementation of regulatory strategy and activities needed to secure approval of new products, including in vitro diagnostics and medical devices.
Provides paraprofessional nursing care within the residential hospice house or travels to patient homes to provide care within the established plan of care.
Work with targeted KOLs to obtain feedback on new RA Franchise and Brand-related marketing strategies/materials. All materials and programs a TLL will request feedback will be approved by legal, compliance and regulatory.
As the Director, Analytical Method Development and Validation (GMP) you will oversee a team of 65+ employees, and will be responsible for all financial, operational and technical activities involved in delivering quality biopharmaceutical testing services to clients.
Actively contribute to and assist with the annual regulatory compliance review and other regular compliance assessments across the business and implement risk mitigation plans.
May take on Global PM, multi- site, or lead project management for key/large clients (> $5MM projects) as well as mentor and support the training of Project Managers.
The lead scientist performs activities related to technical leadership for routine studies in compliance with appropriate protocol, standard operating procedures.
Works with business unit leadership to develop, prioritize and implement marketing efforts that promote brand / system image, products and services across the region.
Identify, develop, plan and execute medical education programs and tactics to support brand strategy and drive healthcare professional awareness, conversion and utilization of Cologuard; strong focus on digital tactics.
Develops organizational strategies by identifying and researching human resources issues; contributing information, analysis, and recommendations to organization strategic thinking and direction.
Explain terms and conditions to managers and interested parties as part of an organized and thorough routing, review and approval process; prepare contract cover sheets and summaries.