Job title: Global Medical Expert
Job description: 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 requir
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. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Location: Hyderabad, Telangana
Job date: Thu, 10 Mar 2022 23:19:41 GMT
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