Global Medical Expert
3d ago

Mission statements

  • 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)
  • Reviewing and approving compassionate use individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials.
  • Secure delivery of high-quality medical documents in time and in compliance with internal and external standards
  • Qualifications

  • Medical Degree; MD.
  • Medical operational excellence, time and risk management skills;
  • Excellent technical (scientific) editing and writing skills;
  • Excellent English language knowledge
  • Requirements of the job

  • 5 years’ experience supporting international pharmaceutical companies : medical affairs, clinical development, pharmacovigilance
  • Experience in at least one of the Therapeutic area - Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, immunology, haematology, radio-oncology, transplant, Anti-infectives, Internal medicine.
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