Medical Manager - Patient Access & Evidence Generation

Czechia, Prague

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Job Purpose:
  • Accountability  for management of Early Access Programs / Compassionate Use Programs  (like SLPs, etc.) across entire Roche innovative portfolio (with focus on oncology, hematology, neurology, immunology, pneumology, etc.)
  • Accountability for management of  Real World Data projects - e.g. Roche support to Investigator Initiated Studies, cooperation with Third Party Registries,  cooperation with professional working groups - across entire Roche innovative portfolio (see above)
  • Cooperation with the Roche Clinical Operations team on new clinical trials feasibilities - to ensure the Medical expertise for feasibility process  in new therapeutic areas
  • Accountability for full implementation and full adherence to  "Publication Policy" across relevant roles in Roche CZ
  • Collaboration on assigned projects  with various relevant teams across  Roche CZ and Roche International (including Drug Safety team, Quality team, Market Access, Drug Regulatory, etc.) 
  • Direct scientific engagement with key external experts involved in the assigned projects 
    Requirements:     
    • University degree in medicine, biology or natural science (MD; PharmDr; RNDr; Mgr. in natural science);  other advanced health/nature science degrees (e.g. PhD) with strong proven therapeutic area experience considered
    • Strong communication skills
    • Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations
    • Experience in development and implementation of clinical trials
    • Experience in the principles and techniques of data analysis, interpretation, and clinical relevance
    • Experience of writing clinical publications and delivery of scientific presentations
    • Relationships with external experts and external organizations is strongly preferred
    • Knowledge of relevant therapeutic area
    • ICH, GCP and local regulations
    • Appreciates the diversity of working with multifunction teams
    • Knowledge of drug discovery & commercialization processes
    • MS office literate
    • Fluent English language knowledge, written and verbal
    • Appreciates and understands the diversity of working with cross-functional teams
    • Professional experience within the pharmaceutical industry (including clinical research organisation)  

    Reporting lines / cooperation:
    • The direct peers are the Medical Managers-Partners focused on clinical expertise in assigned specific therapeutic areas, however, intensive collaboration is expected across entire Roche CZ affiliate (Clinical Operations team, Drug Regulatory Affairs team, Drug Safety Team, Quality team, Logistic department, Market access, etc.) 
    • Direct Report to Country Medical Director