-
developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and guidelines. In this role, you will manage and support the operational process and
-
throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external
-
May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial
-
process, strategic and tactical planning, and the foundational tools that support planning, communication, and continuous improvements in the area of operational delivery. JOB RESPONSIBILITIES Program
-
submission execution, team effectiveness, resource management, risk management, and information and communication management. The GPM needs to have comprehensive understanding of the governance process
-
for process improvement and possible solutions and communicates these to line management or appropriate functional line. BASIC QUALIFICATIONS Bachelor degree or equivalent in medical-related field or life
-
for the use of relevant tools and technologies within the course of the label development and translation process. Work within a framework of internal SOPs, working practices and external regulatory
-
in Medical Affairs experience required Knowledge and experience in Hemophilia/Hematology is preferred Basic understanding of the drug development process Basic knowledge of health care economics and
-
portfolio by implementing a resource planning and forecasting approach to match supply (availability, skills) and demand to fulfill study/project needs. Lead the data / analytics process and reporting