Rosa di Costanzo

Tmf Integration Oversight Manager @诺华

GB

Act as Clinical Document Governance & Management (CDGM) point of contact for assigned portfolio of In-Licensing / Out-Licensing / Acquisition / Divestment Projects, collaborating with key stakeholders with CDGM teams, Development Informatics, Legal, Development Quality Assurance and Global Project Teams.• Lead and/or Contribute to the development of TMF Transition Plans and ensure the successful transitions of TMF (paper and electronic) documentation outside the company in support of out-licensing and divestment projects, and into the company in support of in-licensing and acquisition projects.• Develop and maintain paper and electronic document processes & standards relating to Business Development & Licensing (BD & L) projects and Out-licensing activities, in compliance with internal and external requirements & regulations.• Identify and communicate risks/trends/patterns relating to TMF, BD & L projects, Out-licensing activities, and work with key stakeholders to define and implement pragmatic remediations.• Executes vendor oversight plan, monitors service metrics, and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.• Serves as Subject Matter Expert on TMF transition related training materials, formal and informal processes, and tracking tools for TMF transition oversight activities in collaboration with CDM Process team and other key stakeholders.• Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.• Identify and implement improvements to document management processes to improve quality of TMF integration activities. May act as business lead for innovation projects to enhance integration processes.• Supports the TMF Integration Lead with respect to forecasting and planning of BD & L projects.

Campania Region.

“Experience in protection and enhancement of water resources”, Course I.F.T.S.

Campania Region. Consorzio META (Technical Institute).

"Experience in the management of environmental monitoring", Corso di specializzazione

Università degli Studi di Milano

Masters in Clinical Research

Università degli Studi di Napoli Federico II

Degree in Biology of marine production, Università di Napoli Federico II

I.T.C.G. Archimede

Diploma in Accounting

University of Naples, Federico II, Italy

Degree in Biology of marine production I, Università di Napoli Federico II