Job summary
Works with a team of Medical regulatory writers with different levels of expertise
Develops medical expertise within Medical regulatory writing (on contents, methods, and processes)
Ensures compliance to regulatory requirements from various regions (FDA, EU others) for activities supported
Coordinates and supports medical activities related to the maintenance of the marketing authorizations of the Established and Generic products, in different therapeutic areas.
Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors
Essential Job duties and responsibilities
Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments , Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labelling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs
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
Collaborates effectively with stakeholders : global medical leads / medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams
Knowledge, Skills & Competencies / Language
Therapy Area Exposure : Diabetes, Familial hypercholesterolemia, Cardiovascular disease, Multiple sclerosis, Immunology, Oncology, Market access, Emerging market, Generics, Vaccines, vitamins and supplements, Digestive, Allergies, Parkinson, Haemophilia, Rare diseases, rare blood diseases
Stakeholder management
Project management
Regulatory procedures
Qualifications
Medical Degree; MD.
Medical operational excellence, time, and risk management skills
Excellent technical (scientific) editing and writing skills
Excellent English language knowledge
Any other requirements of the job
5 years’ experience supporting international pharmaceutical companies : medical affairs, clinical development, pharmacovigilance
Experience in at least one of the Therapeutic areas - Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, immunology, hematology, radio-oncology, transplant, Anti-infectives, and 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.
