Global Medical Expert
Works with a team of Medical Scientific writers with different level of expertise
Develops medical expertise within Medical regulatory writing (on contents, methods, processes)
Ensures compliance to regulatory requirements from various regions (FDA, EU others) for activities supported
Coordinates and supports medical activities related to the maintenance the marketing authorizations of the Established and Generics products, in different therapeutic areas.
Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance and vendors
Responsible to provide medical assessment with relevant and updated clinical evidence and to monitor the execution of strategic documents as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments and labelling documents for the corresponding therapeutic area or products.
Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations.
Writing of Key medical/clinical part of Common Technical Document (CTD) or Briefing packages (BP),
Secure delivery of high-quality medical documents in time and in compliance with internal and external standards
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